0930-0158 CCF Comment Matrix

	Agency Information Collection Activities: Proposed Collection; Comments Request 0930-0158 Package Title CCF
	Summary of Comments and SAMHSA’s Responses as of 12/11/2025
Commenter No.	Date Received	Comment No.	Organizations	Comment	SAMHSA’s Response
001	10/17/2025	1	eScreen (Abbott)	When an interview of the donor is required, it is common for the donor to provide a business phone number and a personal phone number to ensure the likelihood of an MRO reaching him/her. Replacing the two date fields for “Daytime Phone No.” and “Evening Phone No.” with a single field “Phone No.” can ultimately affect the donor negatively, especially for post-accident testing.After an accident, the donor is often no longer at work. We have had issues with the employer failing to contact the donor due to termination, depending on the nature of the accident. In the event only a business phone number is provided, this may result in non-contact positive results. To avoid negatively impacting an MRO’s ability to reach a donor for an interview, I oppose reducing the phone numbers down to one.	No change. SAMHSA will maintain a single line for the donor's phone number in Step 5 on Copies 2-5. This will prevent oral fluid device expiration dates for primary/single and split specimens recorded in Step 4 on Copy 1 from obscuring donor information on paper CCFs. The collector should instruct the donor to provide a phone number where they can be reached anytime (day or evening).
002	10/23/2025	1	Patrice Kelly Global Solutions	The burden hours of 0.07 hours (4.2 minutes) per collector are significantly underestimated. The vast majority of CCFs currently approved by SAMHSA’s National Laboratory Certification Program (NLCP) are paper forms. There are very few electronic CCFs approved by NLCP for HHS-certified laboratories, and only one fully electronic CCF has been approved. The majority of collectors need to fill out the paper CCFs, flipping pages between Copy 1 and Copy 2, so that the donor’s information is not conveyed to the laboratory. After that, the collectors must separate the perforated copies and provide one to each intended recipient (Laboratory, Medical Review Officer (MRO), Employer, Employee); with Copy 3 being set aside and then filed at the collection site.	No change. Paperwork Reducation Act (PRA) burden must reflect only the time required to complete the information collection, not operational delays such as printer issues or site-specific workflow bottlenecks. OMB has consistently approved a burden estimate of about 4–5 minutes for the Federal CCF, and this remains appropriate given the standardized nature of the form and automation available through ECCF systems. While some collection sites may experience longer completion times for paper CCFs, particularly during busy periods, PRA guidance requires agencies to use typical, not maximum or problematic, scenarios when calculating burden. ECCF systems also automate several steps, reducing time spent compared to manual hardcopy processes.
002	10/23/2025	2	Patrice Kelly Global Solutions	The burden hours per CCF should be estimated at closer to 7 to 10 minutes, according to an informal poll of industry experts. There are no recordkeeping burden hours accounted for the Collector, MRO, or the Employer to handle and file paper copies of the CCF. SAMHSA also should account for these paperwork burdens of time for the collector to file and maintain a paper copy of the CCF.	No change. Paperwork Reducation Act (PRA) burden must reflect only the time required to complete the information collection, not operational delays such as printer issues or site-specific workflow bottlenecks. OMB has consistently approved a burden estimate of about 4–5 minutes for the Federal CCF, and this remains appropriate given the standardized nature of the form and automation available through ECCF systems. While some collection sites may experience longer completion times for paper CCFs, particularly during busy periods, PRA guidance requires agencies to use typical, not maximum or problematic, scenarios when calculating burden. ECCF systems also automate several steps, reducing time spent compared to manual hardcopy processes.
002	10/23/2025	3	Patrice Kelly Global Solutions	In addition, SAMHSA’s NLCP has created an information collection process they refer to as “creating an ‘authenticated copy’.” This process requires additional paperwork to be generated when there are problems with Copy 1, the Laboratory Copy, of the CCF. Without going into extensive detail to explain this SAMHSA process to SAMHSA, we would respectfully simply submit that the authenticated copy process is an additional information collection and a tremendous paperwork burden and has not been accounted for in this Notice.	No change. The commenter is referring to the authoritative ECCF copy for a combination (electronic and paper) Federal ECCF. The collector prints the ECCF including Copy 1 with the collector's electronic signature at the end of the collection, and sends that authoritative Copy 1 with the specimen bottles in the sealed package to the laboratory. The authoritative copy serves as the official single chain of custody document for the specimen, so must be distinguishable from any reprinted versions. If the collector fails to send the authoritative copy, the collector may sign a reprint ECCF using their wet signature and send that copy to the laboratory by mail or courier. The only time this requirement causes delays is when the form must be reprinted after the specimen has already left the collection site. In that case, the reprinted ECCF cannot replicate the collector’s wet signature, which necessitates reconciliation.
002	10/23/2025	4	Patrice Kelly Global Solutions	We support SAMHSA’s proposal to make the changes to replace the “Daytime Phone No.” and “Evening Phone No.” fields with the single field of “Phone No.”. Most individuals can be reached at a single phone number. Removing the extra space preserves much needed “real estate on the CCF” and reduces the paperwork burden for the donor and collector.	The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5. SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
002	10/23/2025	5	Patrice Kelly Global Solutions	We applaud SAMHSA for proposing to move the “Date of Birth” field because this will allow the Donor to include their Date of Birth, as well as the date they signed the CCF, without interfering with the equally important data element for oral fluid tests of “Split Specimen Device Expiration Date.” Incidentally, the National Drug and Alcohol Screening Association (NDASA) identified this problem and brought it to the attention of DOT and SAMHSA. As one of the first NDASA trainers for its Oral Fluid Train the Trainer course and as a current NDASA member, I very much appreciate this change.	The commenter agreed with the proposal to move the Date of Birth line in Step 5 on Copies 2-5. SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
002	10/23/2025	6	Patrice Kelly Global Solutions	We strongly encourage SAMHSA’s NLCP to move beyond having approved just one paperless CCF. We urge NLCP to solicit HHS-certified Laboratories to submit and for NLCP to approve paperless electronic CCFs. If NLCP approves more paperless CCFs, making them available to HHS-certified Laboratories and their clients, there would be a significant reduction on the paperwork burden for all CCF users. Admittedly, there are certain locations where the use of paperless forms are presently difficult – such as remote oil fields where certain DOT-regulated tests occur. However, with the approval of more than one paperless CCF and the advancement of downloadable electronic CCFs that could be completed in remote locations that do not have Internet reception, most electronic CCFs should be able to be deployed. As the Internet continues to reach more locations, the existence of “dead zones” will continueto decrease until, one day, Internet reception boundaries will disappear.	[Threaded comment] Your version of Excel allows you to read this threaded comment; however, any edits to it will get removed if the file is opened in a newer version of Excel. Learn more: https://go.microsoft.com/fwlink/?linkid=870924 Comment: Does SAMHSA intend to list all of the “Recognized ECCF Systems” on its website? Picking some to list and not all could raise endorsement ethical concerns. No change. SAMHSA has taken steps to enable all HHS-certified test facilities to implement a digital ECCF. Actions include delaying the required submission date by 3 years; providing an NLCP consultant at no charge to companies interested in developing a digital ECCF "standalone" system that could be used by any HHS-certified test facility; reducing and/or waiving fees for ECCF providers and test facilities; and implementing an ECCF System Recognition Program for standalone systems that meet program requirements. The NLCP has procedures in place for ECCF providers, applicant test facilities, and HHS-certified test facilities. SAMHSA will post a list of Recognized ECCF Systems on their website.
003	11/3/2025	1	CRL	We propose that SAMHSA’s extension request seeks an extension of the 2023 Federal CCF until August 31, 2029, and that the use of the 2023 Federal CCF be permitted without a memorandum for the record (“MFR”). We request that the extension apply to all specimens collected for federal workplace drug testing programs and those collected under the Department of Transportation (“DOT”) regulations. Our position is primarily based on the disruptive impact the new form will have on market participants, including employers and employees. Past experience has shown that market participants will use outdated forms when the new forms are not available or easily located. In such a case, we as the laboratory are tasked with obtaining an MFR. Even when this process works as designed, there are delays in reporting results. These delays most notably affect pre-employment drug tests and an individual’s ability to return to work. And where we are unable to obtain an MFR, the donor must submit to a second collection that will cause inconvenience and further delay the process. Despite the CCF formatting concerns first being raised in early 2025, the market has continued to operate efficiently and effectively for the year. SAMHSA and the National Laboratory Certification Program (“NLCP”) issued a notice on February 7, 2025 detailing the underlying issues that prompted the proposed form updates. In its March 25, 2025 notice, NLCP instructed Department of Health and Human Services (“HHS”)-certified laboratories to “[m]odify their Federal CCF format and/or material to prevent Step 4 annotations from obscuring donor information in Step 5 of Copies 2-5.” It is our understanding that most laboratories have taken this action already and received approval from NLCP regarding their respective modified CCFs. Thus, the proposed changes are not urgently required to maintain operational integrity. The costs of destroying pre-printed hardcopy 2023 Federal CCFs and printing new forms are disproportionate to the limited impact these changes will have, especially given the continued high adoption of electronic CCFs and the fact that the identified issues are primarily limited to oral fluid collections. Compounding this issue, the printing of new CCFs introduces significant logistical risks as there is massive supply chain volatility in the market, including disruption caused by the closure of domestic NCR papermills—resulting in shortages of carbonless paper, limited availability of specialized printing contractors, and short supplies of resins and plastics used for labeling. Furthermore, the mandated destruction of hundreds of thousands of existing hardcopy forms and the consumption of new resources for printing and distributing replacements are contrary to broad goals of environmental sustainability and waste reduction, especially given the viable and efficient electronic CCFs.	No change. SAMHSA will issue separate guidance regarding continued use of pre-printed 2023 CCFs.
003	11/3/2025	2	CRL	While we support updating the CCF to better align with social trends (e.g., most individuals utilize one phone number for all purposes), the most practical solution is to allow for the full exhaustion of hardcopy CCFs currently printed and in the field. We appreciate SAMHSA’s willingness to request OMB approval for an extension and the opportunity to provide our comments. Given the effect on market participants, the costs of printing new hardcopy forms, and the market shifting to electronic CCFs, we request that the extension sought last until August 31, 2029.	No change. The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5. SAMHSA will issue separate guidance regarding continued use of pre-printed 2023 CCFs.
003	11/3/2025	3	CRL	The United States is continually under attack by new and designer drugs, and sometimes by the reemergence of old drugs of abuse. The incidence and prevalence of a drug of abuse is continually changing and impacted by many factors, including enforcement efforts, laboratory detection capabilities, and costs. HHS’s 2023 modifications to its process for adding and removing drugs/analytes from its drug testing panel allows it to be more responsive to drug use trends and provides needed flexibility based on the state of science. This new flexibility has to potential to render the then-current CCF out-of-date as new drugs/analytes are added to the panel. The market’s shift toward electronic ordering and CCFs render the listing of drugs on the CCF unnecessary and obsolete. The listing of drugs as part of “Drug Test to be Performed” adds minimal value compared to the disproportionate expense of printing new hardcopy CCF forms, particularly when considering the current paper supply chain issues. We request that the updated CCF no longer include the listing of specific drugs. During the extension of the 2023 Federal CCF, we implore SAMHSA to seek agreement and clarification that the completion of Step 1.F. will not be required and there will be no requirement to obtain an MFR based on the addition of new drugs/analytes to the HHS or DOT authorized drug testing panels.	SAMHSA agrees with removing drug analytes from the Federal CCF and has revised Step 1, item F of the proposed Federal CCF accordingly.
004	11/3/2025	1	bge (bge.com)	Fully Electronic CCF. As an MRO-A for 20 years, getting the MRO copy of the CCF from collection sites in a legible, legal format is nearly impossible. We struggle for weeks sometimes to get the copies to us, as the collection site claims they mailed it, or they have faxed or scanned it but it is never readable. Providers like FormFox are wonderful, as the data is entered into their system, filled in via typed letters on all the copies and automatically sent to the MRO.	No change. SAMHSA has taken steps to enable all HHS-certified test facilities to implement a digital ECCF. Actions include delaying the required submission date by 3 years; providing an NLCP consultant at no charge to companies interested in developing a digital ECCF "standalone" system that could be used by any HHS-certified test facility; reducing and/or waiving fees for ECCF providers and test facilities; and implementing an ECCF System Recognition Program for standalone systems that meet program requirements. The NLCP has procedures in place for ECCF providers, applicant test facilities, and HHS-certified test facilities. SAMHSA will post a list of Recognized ECCF Systems on their website.
004	11/3/2025	2	bge (bge.com)	Istead of having the email address in step 5, just remove it. Again, as an MRO-A I have never used this to attempt to make contact with a donor for the interview with the MRO. Most donors simply draw a line through it and it is taking up valuable "real estate" on the CCF as it is.	No change. SAMHSA will maintain the email line as an additional means to contact the donor.
004	11/3/2025	3	bge (bge.com)	Daytime and Evening phone numbers, pick one as suggested. However, if you remove one of them and remove the email address, make the area for the phone number bigger (longer) as most donors have a near impossible time trying to it the numbers into the small spaces.	The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5. SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
004	11/3/2025	4	bge (bge.com)	Remove the Specimen Bottle release to. This is a ridiculous box, as it has NOTHING to do with the actual collection process. If this box is missing a check, the labs will pull this out of testing, setting it aside until the MFR is completed and returned. Not checking this box causes unnecessary as the specimen arrived.	[Threaded comment] Your version of Excel allows you to read this threaded comment; however, any edits to it will get removed if the file is opened in a newer version of Excel. Learn more: https://go.microsoft.com/fwlink/?linkid=870924 Comment: Edited the word “chain” in this response. No change. The Federal CCF is the chain of custody document for the specimen. All handling must be documented proactively. Couriers, express carriers, and postal service personnel are not required to document chain of custody on the Federal CCF only because specimens are sealed in packages that would indicate tampering during transit to the HHS-certified test facliity.
005	11/3/2025	1	SAPAA	SAPAA supports the proposed CCF revisions to move the “Date of Birth” field to the left by combining the “Daytime Phone No.” and “Evening Phone No.” into a single field called “Phone No.” However, we also recommend that the email address line be as long as the resulting space will allow, ideally a minimum of three (3) inches, to accommodate different types of handwriting.	The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5. SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
005	11/3/2025	2	SAPAA	This recommendation reflects “boots on the ground” reports from members. There is no baseline formatting consistency across laboratories today. Paper CCFs supplied by different labs vary in line length and spacing, producing uneven completion experiences at collection sites.	No change. SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
005	11/3/2025	3	SAPAA	With the current uncertainty regarding the scheduling of marijuana, SAPAA suggests that there should be consideration for the removal of the specific drugs listed in Step 1 F from the Federal Custody and Control Form. If marijuana is down- scheduled, this might require the removal of "THC" from the Federal test panel. If so, a further revision of the Federal CCF would be required at significant cost to employers, laboratories and other service agents. Since Federal Agencies have the ability to request testing of other Schedule I and II drugs, Line F should remain on the form and could be relabeled as “Other tests to be performed (specify)”. This would allow agencies or MROs to direct additional testing when appropriate; and could reduce collector error, eliminate outdated or inconsistent references,improve adaptability of the form, and ensure that panel specifications are communicated directly between the agency/employer and the laboratory. The distinct checkboxes for Testing Authority (Step 1D), HHS, NRC, and specific DOT agencies, should be retained, with each checkbox reflecting the standard panel under that authority’s statutory and regulatory framework, and with selection errors corrected through a memorandum for record.	SAMHSA agrees with removing drug analytes from the Federal CCF and has revised Step 1, item F of the proposed Federal CCF accordingly.
006	11/4/2025	1	Airlines for America (A4A)	We strongly oppose SAMHSA’s proposal to shorten the email address line. The line is already too short to accommodate long email addresses. Moreover, email addresses are typically not constrained to a character limit, allowing donor to have long email addresses that may reflect long names and/or long email domains.	SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
006	11/4/2025	2	Airlines for America (A4A)	We support SAMHSA’s proposal to replace the two fields for “Daytime Phone No.” and “Evening Phone No.” with a single field “Phone No.” It is uncommon for donors to have separate contact phones, particularly with the significant proliferation of mobile phones and reduced use of home phones. Moreover, the single field will allow for a longer email address line, as recommended above. Removal of a phone number will also allow for SAMHSA to retain the longer email address and current positioning of the birth date field.	The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5. SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
006	11/4/2025	3	Airlines for America (A4A)	To further reduce the burdens imposed upon industry with the CCF, we also encourage SAMHSA to communicate its support for the expansion of the use of electronic CCFs and the acceptance of electronicsignatures on all copies, particularly by the DOT.	No change. SAMHSA routinely meets with federal partners including DOT on topics of interest including the HHS Federal CCF.
007	11/4/2025	1	NDASA	The Federal Drug Testing Custody and Control Form (CCF) is the standard for CCFs in both federally mandated and non-regulated testing programs. The information collected is necessary for the proper performance of not only SAMSHA, but also for Federal agencies that conduct drug testing, and DOT-regulated industries that use the CCF for more than 6.7 million tests per year. It is important to note that the Federal CCF is the primary training tool used by thousands of industry trainers as a guideline for how to properly conduct a federal drug test. Therefore, each and every step is invaluable to create consistency among the collection’s professionals in the U.S. To be clear, we welcome the opportunity to use electronic forms, however there are still challenges in many parts of the country with reliable internet connections and often we hear that the technological upgrades are costly to small businesses who cannot afford to integrate tablets, etc. into their workflows. We believe the day will come when the paper CCF is used less than the electronic systems, but that time has not yet come for this industry, and the paper is heavily relied upon.	No issue raised. SAMHSA agrees that paper Federal CCFs will be needed (e.g., in the event of ECCF equipment failure).
007	11/4/2025	2	NDASA	The burden hours of 0.07 hours (4.2 minutes) per collector for a collection scenario is substantially in error. The majority of CCFs currently approved by SAMHSA’s National Laboratory Certification Program (NLCP) are paper forms. There are very few electronic CCFs approved by NLCP for HHS-certified laboratories, and only one fully electronic CCF has been approved. A typical collection without incident takes on average 7 – 10 minutes from start to finish. Most collectors fill out the hard copy of the CCF with information provided on a service order; they must switch between Copy 1 and Copy 2, so that the donor’s information is not conveyed to the laboratory. The collector then must separate the perforated copies and provide one to each intended recipient (Laboratory, Medical Review Officer (MRO), Employer, Employee); with Copy 3 being set aside and then filed at the collection site. Recordkeeping hours should be accounted for as the Collector, MRO, and the Employer must all review and file paper copies of the CCF. In addition, SAMHSA’s NLCP has created an information collection process they refer to as “creating an ‘authenticated copy’.” This process requires additional paperwork to be generated when there are problems with Copy 1, the Laboratory Copy, of the CCF which does happen frequently. This process is an additional information collection and a tremendous paperwork burden and has not been accounted for in this Notice.	No change. Paperwork Reducation Act (PRA) burden must reflect only the time required to complete the information collection, not operational delays such as printer issues or site-specific workflow bottlenecks. OMB has consistently approved a burden estimate of about 4–5 minutes for the Federal CCF, and this remains appropriate given the standardized nature of the form and automation available through ECCF systems. While some collection sites may experience longer completion times for paper CCFs, particularly during busy periods, PRA guidance requires agencies to use typical, not maximum or problematic, scenarios when calculating burden. ECCF systems also automate several steps, reducing time spent compared to manual hardcopy processes.
007	11/4/2025	3	NDASA	[Threaded comment] Your version of Excel allows you to read this threaded comment; however, any edits to it will get removed if the file is opened in a newer version of Excel. Learn more: https://go.microsoft.com/fwlink/?linkid=870924 Comment: This comment response is duplicative of the one of above. Consider whether it’s needed. In addition, SAMHSA’s NLCP has created an information collection process they refer to as “creating an ‘authenticated copy’.” This process requires additional paperwork to be generated when there are problems with Copy 1, the Laboratory Copy, of the CCF. Without going into extensive detail to explain this SAMHSA process to SAMHSA, we would respectfully simply submit that the authenticated copy process is an additional information collection and a tremendous paperwork burden and has notbeen accounted for in this Notice.	No change. The commenter is referring to the authoritative ECCF copy for a combination (electronic and paper) Federal ECCF. The collector prints the ECCF including Copy 1 with the collector's electronic signature at the end of the collection, and sends that authoritative Copy 1 with the specimen bottles in the sealed package to the laboratory. The authoritative copy serves as the official single chain of custody document for the specimen, so must be distinguishable from any reprinted versions. If the collector fails to send the authoritative copy, the collector may sign a reprint ECCF using their wet signature and send that copy to the laboratory by mail or courier. The only time this requirement causes delays is when the form must be reprinted after the specimen has already left the collection site. In that case, the reprinted ECCF cannot replicate the collector’s wet signature, which necessitates reconciliation.
007	11/4/2025	4	NDASA	We support SAMHSA’s proposal to make the changes to replace the “Daytime Phone No.” and “Evening Phone No.” fields with the single field of “Phone No.”. Most individuals can be reached at a single phone number. Removing the extra space preserves much needed “real estate on the CCF” and reduces the paperwork burden for the donor and collector.	The commenter agreed with the proposal to include a single line for the donor's phone number in Step 5 on Copies 2-5.
007	11/4/2025	5	NDASA	We would also recommend extending the space for the Donor to write their email address as the current space for this is far too short to legibly write the average email address.	SAMHSA has made additional edits to the Federal CCF to facilitate legible donor entries, including extending the lines for the email address and phone number without interfering with the expiration date entries that are carried through from Copy 1 of the CCF. Note that SAMHSA allows test facilities to make minor formatting edits to facilitate completion. Collection sites should contact the individual laboratory or IITF with concerns.
007	11/4/2025	6	NDASA	After conducting hundreds of trainings for collectors that will perform federal oral fluid tests, NDASA strongly urges SAMHSA to move the fields for the device expiration dates up into Step 2 of the CCF. The reasoning for this is that collectors have been trained for decades not to write below their signature line on the CCF. Re-training them to change this practice and now write in a section that is reserved for the laboratory personnel is against all common sense and good practice for the experienced collector. We have also used the methodology of CCF completion in an order of (Steps) “1 – 2 – 3 – 5 – 4” for over 25 years and our body of expert trainers are very adamant that this should continue as proper protocol for correct CCF completion. We expect without this change that the labs will have a burden of incomplete CCFs when federal oral fluid testing begins. We understand the original intent was that the lab personnel would enter the expiration dates, but when this process was changed to the collector (which NDASA supported and agrees with) we now request that the CCF be brought into harmony. We propose that the expiration date be moved to the top of Step 2, next to the “None Provided” box. We greatly appreciate SAMHSA’s attention to this important update.	No change. HHS allows either the collector or the laboratory accessioner to record the manufacturer’s expiration date on the A specimen tube as the Primary/Single Specimen Device Expiration Date in Step 4 of the Federal CCF and record the manufacturer’s expiration date on the B specimen tube as the Split Specimen Device Expiration Date in Step 4 of the Federal CCF.. However, if the collector records the expiration dates, it is the laboratory's responsibility to verify that information. Therefore, the expiration date will remain the laboratory section of Step 4.
007	11/4/2025	7	NDASA	We understand that SAMHSA has heard for many years that the “Remarks” section in Step 2 should be increased to provide more space to document odd circumstances in collections. This box is used much more frequently than SAMHSA may expect, particularly in cases of shy bladder documentation and attempts to dilute/substitute specimens, or refusals to test. While we certainly recognize the space challenges on the Federal CCF, it has been brought to our attention by our Council of Collectors that the “Specimen Bottle(s)/Tube(s) Released to” segment in Step 4, is unnecessary in modern times, as the shipping companies no longer sign for specimens as part of the custody process. If that box were to be removed, as it is an antiquated section of the form, this would allow for much more space to increase the Remarks section and in fact create spacing for the oral fluid expiration dates. We feel these are simple changes that would modernize the form and make use much easier for the collector.	No change. The Federal CCF is the chain of custody document for the specimen. All handling must be documented proactively. Couriers, express carriers, and postal service personnel are not required to document chain of custody on the Federal CCF only because specimens are sealed in packages that would indicate tampering during transit to the HHS-certified test facliity.
007	11/4/2025	8	NDASA	NDASA would also like to request clarification in the Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection. We believe that simply adding a few words at the beginning of Step 2 would prevent some common mistakes from occurring. Simply put, in Step 2, in the first bullet point, adding, “After the specimen has been collected,” before the words, “collector checks the Split or Single specimen collection box” would clarify that the collector should not fill out Step 2 prior to the collection, but after the specimen has been collected.	No change. The collector should always mark the Split checkbox for federally regulated specimens. All federally regulated urine drug testing programs under HHS, DOT, and NRC require split specimen collections, and single-specimen urine collections are not permitted under these programs. While the Federal CCF is designed specifically for federal and federally regulated use, it is also widely utilized in non-federal testing programs that rely on the existing format. Eliminating the “Single Specimen” checkbox may significantly disrupt current operational workflows for laboratories, ECCF vendors, and collection sites, and would increase national burden under the PRA. For these reasons, the checkbox will remain on the CCF, and all regulated programs will continue to require split-specimen collections.
007	11/4/2025	9	NDASA	Finally, NDASA would like consideration to be given on whether or not line “F” in Step 1 is still relevant in Federal drug testing programs. If selecting the panel of drugs is an outdated set of options, perhaps the choices for “Drug Tests to be Performed” could simply be, “Federal” or “DOT” as drug test panels seem to be highly standardized to the 5 Panel.	SAMHSA agrees with removing drug analytes from the Federal CCF and has revised Step 1, item F of the proposed Federal CCF accordingly.
007	11/4/2025	10	NDASA	NDASA recommends that SAMHSA’s NLCP move beyond having approved only one paperless CCF. We would hope to see NLCP solicit and approve HHS-certified Laboratories’ electronic CCF systems, for greater accessibility to employers and collectors nationwide. If NLCP were to approve more paperless CCFs, making them available to HHS-certified Laboratories and their clients, we believe there would be a significant reduction on the paperwork burden for all CCF users.	No change. SAMHSA has taken steps to enable all HHS-certified test facilities to implement a digital ECCF. Actions include delaying the required submission date by 3 years; providing an NLCP consultant at no charge to companies interested in developing a digital ECCF "standalone" system that could be used by any HHS-certified test facility; reducing and/or waiving fees for ECCF providers and test facilities; and implementing an ECCF System Recognition Program for standalone systems that meet program requirements. The NLCP has procedures in place for ECCF providers, applicant test facilities, and HHS-certified test facilities. SAMHSA will post a list of Recognized ECCF Systems on their website.