0046 Imports SSA REV 2020

UNITED STATES FOOD & DRUG ADMINISTRATION
Imports; and Electronic Import Entries
21 CFR Part 1 – General Enforcement Regulations;
Subparts D and E
OMB Control No. 0910-0046 - Revision
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us
or we) regulations found in 21 CFR part 1 of our General Enforcement Regulations
pertaining to imports and electronic import entries; specifically 21 CFR part 1, subparts D
and E (21 CFR §§ 1.70-1.101). Section 801 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) charges the Secretary of Health and Human Services (HHS), through the
FDA, with the responsibility of assuring the safety of FDA-regulated foods, drugs,
cosmetics, medical devices, radiological health, and tobacco products offered for import
into the United States. This responsibility is met through coordination and cooperation
between FDA headquarters and field inspection personnel and the U.S. Customs and
Border Protection (CBP) Service. Agency regulations prescribe required data elements
that respondents must submit when importing, or offering for import, an FDA-regulated
article into the United States. Review of the data elements allows us to continue to meet
our responsibilities pertaining to current submission requirements established by the U.S.
CBP related to the submission of entry information in using its Automated Commercial
Environment (ACE) system, or any CBP-authorized electronic data interchange (EDI)
system, as well as agency regulations.
Respondents (ACE filers) submit important and useful information about FDA-regulated
products being imported or offered for import into the United States so that we may
effectively and efficiently review products and determine their admissibility. In addition,
and as set forth in the regulations, certain product types are subject to additional data
elements (for example, 21 CFR 1.77 prescribes additional data elements for radiationemitting products), as well as those data elements applicable to all products.
We are revising the information collection to provide for a weekly entry filing program
(WEF). More detailed information on Foreign Trade Zones (FTZ)/WEF, is available at
https://www.fda.gov/industry/import-basics/foreign-trade-zonesweekly-entry-filing. The
WEF program, which is available for some FDA-regulated products, allows entry filers to
file a single entry estimating the amount of merchandise anticipated to be removed from an
FTZ and offered for U.S. consumption during a 7-day period. To participate, we
recommend respondents who wish to file a weekly entry of FDA-regulated products with
CBP to first request a preliminary assessment from FDA. As part of this assessment, we
recommend submission of the following information:

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FDA Import Division(s) with geographic oversight over the FTZ location;
Identification of whether products are manufactured or stored in the FTZ;
FTZ site/subzone number and address;
Importer of Record (IOR) Facility Establishment Identifier (FEI), if known;
Manufacturer FEI, if known; and
Port of entry.

The division information is necessary so that we can appropriately route the submission
within the Agency. Information on whether the product is stored or manufactured in the
zone is necessary for FDA to determine the applicable admissibility requirements. The
FTZ and port information is necessary to ensure that basic requirements in 19 CFR part
146 are met. The IOR and manufacturer FEI information is requested by FDA to expedite
the admissibility review. Requests to participate in the WEF process are submitted to the
FDA Import Division Office covering the intended port of entry.
We are also revising the information collection to include our Import Trade Auxiliary
Communication System (ITACS), currently approved under OMB control number 09100842. The ITACS is used by the import trade community and was implemented to
improve communication with FDA. By utilizing ITACS, respondents to the information
collection have the ability to establish an account and electronically check the status of
FDA-regulated entries and lines, submit entry documentation, submit the location of goods
availability for those lines targeted for examination by FDA, and check the estimated
laboratory analysis completion dates for lines that have been sampled. For further
information regarding ITACS, please visit our website at
https://www.fda.gov/industry/import-systems/itacs.
For operational efficiency we are including Form FDA 766 “Application for Authorization
to Relabel or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and
Other Related Acts” (currently approved under OMB control number 0910-0025) as the
collection instrument associated with 21 CFR 1.95. Form FDA 766 facilitates collection of
information associated with certain general enforcement provisions for importing FDAregulated articles into the United States. The form is available on the internet at
https://www.fda.gov/industry/actions-enforcement/reconditioning.
Relatedly, we also are revising the information collection to include reference to agency
guidance pertaining to importing drug products entitled “Pre-Launch Activities
Importation Requests (PLAIR).” Historically, when applicants with a pending new drug
application, abbreviated new drug application, or Center of Drug Evaluation and Researchregulated biologics licensing application (information collection associated with these
submissions is currently approved under OMB control number 0910-0001) sought to
import unapproved finished dosage form drug products into the United States in
preparation for market launch, we considered such requests, informally referred to as
“PLAIRs,” on a case-by-case basis. Since implementing the PLAIR program in 2013,
interest continues to increase and we have therefore worked to develop a more formalized

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process. To facilitate submissions and improve our own efficiencies, we developed the
draft guidance. We intend to finalize the guidance document to further clarify our
recommendations on what products are eligible for a PLAIR, what information should be
included in a PLAIR submission, when and how a PLAIR can be submitted to FDA, and
the circumstances under which the agency intends to grant a PLAIR. The draft guidance is
available from our website at: https://www.fda.gov/drugs/guidance-complianceregulatory-information/human-drug-imports and is being issued consistent with our good
guidance practice regulations in 21 CFR 10.115, which provide for public comment on
agency guidance documents at any time.
2. Purpose and Use of the Information Collection
The respondents to this collection of information are importers of FDA-regulated products
who are private businesses importing goods from foreign countries. The information
collection is used to determine product compliance and admissibility.
3. Use of Improved Information Technology and Burden Reduction
The information collection is effected through the submission of information and
electronic interface between FDA systems and the ACE System utilized by CBP. We
estimate 100% of respondents will utilize electronic means to provide the information.
FDA has also developed ITACS, as discussed above, and other reporting and tracking
systems to minimize burden on respondents and increase agency efficiencies in reviewing
the necessary information collection.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
The information provided by filers is voluntary and we do not believe it imposes any
undue burden on small entities. If needed, filers can obtain assistance from their local
FDA district, as well as from agency resources available on our website at www.fda.gov.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory and regulatory
requirements and is driven by respondents who elect to import FDA-regulated products
into the United States. Because of the very large number of FDA-regulated products
imported to the U.S. each year, FDA cannot physically examine every FDA-regulated
article. Therefore, it is essential that we receive reportable information.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Information for this data collection is reported to FDA each time a shipment is imported
into the United States by the respondent to allow FDA to either accept each line of the
shipment, or indicate that product requires further FDA review. Also, under 19 CFR
163.4(a) filers are required to retain all entry documents for five years after the date of
entry.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60 day notice soliciting public
comment for the information collection in the Federal Register of January 3, 2020 (85 FR
318). No comments were received.
In addition, in the Federal Register of July 24, 2013 (78 FR 44572), we announced a draft
guidance document discussing our PLAIR program, including an analysis under the PRA
of the burden we estimate is attributable to the applicable information collection activity.
No comments were received regarding the utility of the information collection or the
burden estimates we ascribed.
9. Explanation of Any Payment or Gift to Respondents
No payment or gift was provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
No assurance of confidentiality has been provided except as generally considered in review
guidelines in 21 CFR 20.61.
11. Justification for Sensitive Questions
There were no questions asked of a sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
12a Annualized Hour Burden Estimate:
21 CFR Part 1, Subpart D

Importers submission of data
elements (preparing the
required information)
Entry filers (unique lines
only)

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of
Total Annual
Respondents Responses per
Responses
Respondent
85,480
10.05
859,074

3,419

12,196

41,698,124

15

1

15

500

1

1

324

1

324

WEF participants
ITACS; creation of new
account
Form FDA 766

Avg. Burden
per
Response
0.05576
hours
(3.346
mins.)
0.04466
hours
(2.68 mins.)
0.87 hours
(52 mins.)
0.5
(30 mins.)
0.25
(15 mins.)
16

Total Hours

47,902

1,862,238

13.05
250
81

Submissions in accordance
70
5
350
5,600
w/PLAIR
Total
42,557,888
1,916,084
1
There are no capital or operational and maintenance costs associated with the information collection.

12b. Annualized Cost Burden Estimate
The total estimated cost burden for this collection of information is based upon performing
a similar position in the government as private industry. The cost to respondents is
estimated to approach the hourly cost of a GS-10, step 5 worker, or $31 per hour.
Therefore, the cost associated with this collection is $ 59,398,604.
Type of
Respondent

Total Burden
Hours

Hourly Wage Rate

Total Respondent
Costs

Industry Analyst

1,916,084

$31.00

$59,398,604

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
We estimate an annual cost to the Federal government of $38,750,000 to reflect the
allocation of 155 FTE’s, assuming a loaded cost of $250,000 per employee. This is based
on previous formulations found in our impact analysis in support of recent rulemaking
(0910-AH41) for which we have made no adjustment.

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15. Explanation for Program Changes or Adjustments
The information collection reflects program changes as well as adjustments. We have
made a number of revisions to the collection to streamline agency operations. We are
introducing a weekly entry filing program (WEF) for respondents; we are consolidating
burden from related information collection activity (ITACS); and we are adding collection
instruments. Specifically, Form FDA 766 associated with relabeling and reconditioning
products under 21 CFR 1.95 is being added to the collection to align with the regulation;
we currently account for this burden elsewhere (0910-0025). Also, we are adding agency
guidance pertaining to the import of drug products covered by our PLAIR program.
Finally, we are removing one-time burden associated with rulemaking (0910-AH41) that
we believe has since been realized by respondents. Cumulatively, these changes and
revisions result in 40,111,035 fewer annual responses and 130,572 less burden hours to the
information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
No tabulation of the data is planned or anticipated, however general information regarding
FDA import activities may be found at https://www.fda.gov/industry/import-programfood-and-drug-administration-fda.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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