SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the act (21 U.S.C. 321) provides an exemption from the definition of ‘‘food additive’’ and thus from the premarket approval requirement, for uses of substances that are Generally Recognized as Safe (GRAS) by qualified experts. In April 1997, FDA proposed a voluntary procedure whereby manufacturers would notify FDA about a view that a particular use (or uses) of a substance is not subject to the statutory premarket approval requirements based on a determination that such use is GRAS (62
FR 18938, April 17, 1997). Proposed §§ 170.36 and 570.36 (21 CFR 170.36 and 570.36) provide a standard format for the voluntary submission of a notice. The notice would include a detailed summary of the data and information that support the GRAS determination, and the notifier would maintain a record of such data and information. FDA would make the information describing the subject of the GRAS notice, and the agency’s response to the notice, available in a publicly accessible file; the entire GRAS notice would be publicly available consistent with the Freedom of Information Act and other Federal disclosure statutes.
FDA requests extension of OMB approval of the GRAS notification procedure set forth in proposed §§ 170.36 and 570.36.
2. Purpose
and Use of the Information Collection
The
information is used by FDA to evaluate whether the notice provides a
sufficient basis for a conclusion of GRAS status and whether
information in the notice or otherwise available to FDA raises issues
of public health significance that lead the agency to question
whether use of the substance is GRAS.
3. Use
of Improved Information Technology and Burden Reduction
The
proposed regulation does not specifically prescribe the use of
automated, electronic, mechanical, or other technological techniques
or other forms of information technology as necessary for use by
firms. Companies are free to use whatever forms of information
technology may best assist them in preparing the notice and
submitting it to FDA. The information in the notice will be
narrative text that the agency would read rather than data that the
agency would either analyze or store in a database format. FDA
would print and copy any notice submitted electronically. Therefore,
for efficient enforcement of the act, FDA is requiring the submission
of paper copies of the notice. However, FDA is aware that there is
an increasing interest in submitting an electronic copy of
information prepared for regulatory purposes. Therefore, in the
proposed rule FDA requested comment on whether it would be
appropriate to require or recommend that the submission include an
electronic copy, in addition to the three paper copies required under
the proposed regulation, of the information in the notice. FDA also
specifically requested comment on the narrower question of whether it
would be appropriate to require or recommend that the notifier
include an electronic copy of the notice’s “GRAS
exemption claim,” which would include succinct descriptions of
the notified substance and applicable conditions of use, to maximize
the agency’s flexibility in making such claims publicly
accessible. Most of the comments to the proposed rule encouraged FDA
to recommend, but not require, submission of an electronic copy of
the GRAS notice.
4. Efforts
to Identify Duplication and Use of Similar Information
No
duplication of Federal regulations is likely. Under the Meat and
Poultry Inspection Acts, the United States Department of
Agriculture’s Food Safety and Inspection Service (USDA/FSIS)
has regulatory authority for meat and poultry. Recently, USDA/FSIS
(64 FR 72167; December 23, 1999) and FDA (65 FR 51758; August 25,
2000) amended their regulations to harmonize and improve the
efficiency of the procedures used by USDA/FSIS and FDA with respect
to reviewing and approving the use of substances in meat and poultry.
In general, USDA/FSIS evaluates food substances as to their
suitability for specified uses in meat or poultry products. When
USDA/FSIS receives a request to evaluate the suitability of a
substance for use in meat or poultry products, USDA/FSIS consults
with FDA about the regulatory status of the substance. When FDA
receives a GRAS notice that includes a use in meat or poultry
products, FDA consults with USDA/FSIS and provides to the notifier
feedback from USDA/FSIS about the suitability of the substance for
use in meat or poultry products. If USDA/FSIS informs FDA that the
use of the substance in meat or poultry products requires rulemaking
under the statutes that FSIS implements, FDA provides that
information to the notifier. FDA and USDA have now signed a
Memorandum of Understanding regarding these procedures
[http://www.fsis.usda.gov/OA/topics/mou_fda.htm].
5. Impact
on Small Businesses or Other Small Entities
The
proposed notification procedures are no more burdensome for small
businesses than for large. The proposed requirements are the minimum
requirements to provide a sufficient basis for a conclusion of GRAS
status. The proposed notification procedure would minimize the
burden on all businesses, including small businesses, by providing
that the notifier submit a detailed summary of the data and
information, rather than the data and information itself, that are
the basis for the conclusion of GRAS status.
6. Consequences
of Collecting the Information Less Frequently
The
data in a GRAS notification are submitted only once and therefore
cannot be collected less frequently. If
the information was not collected, FDA would utilize more resources
answering questions about the regulatory status of substances that
are not explicitly authorized by the agency’s regulations
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
The
proposed GRAS notification program does not involve submission of
information more than quarterly, written responses to the agency in
less than 30 days, submission of more than an original plus two paper
copies of the notification, or the use of statistical methods not
reviewed by OMB.
The proposed GRAS notification program would, however, require that records be retained for more than three years. Under the proposal, notifiers would supply a detailed summary of the information that provides the basis for a conclusion of GRAS status rather than the information itself. As a result, FDA proposed to require that the notifier retain the information that forms the basis for the conclusion of GRAS status and sign a statement that such information is available for FDA review and copying at reasonable times or will be sent to FDA upon request.
With regard to the confidentiality of the information or the submission of trade secrets or proprietary information, the agency expects that it may receive notifications containing trade secrets or confidential commercial information. Trade secrets and confidential commercial information are protected from disclosure under the Freedom of Information Act under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the agency’s regulations (21 CFR part 20). Consistent with confidentiality requirements, FDA will make accessible to the public the information in the “GRAS exemption claim” and the agency's response to the notice through an electronic inventory of GRAS notices posted on the agency’s Web site at http://www.cfsan.fda.gov/~rdb/opa-gras.html. In addition, FDA posts on the agency’s Web site the complete text of frequently requested GRAS notices (after removal of any trade secrets or other confidential information) (at http://www.cfsan.fda.gov/~prise/prisesum.html).
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of February 11, 2009 (74 FR
6894). No comments were received.
9. Explanation
of Any Payment or Gift to Respondents
This
information collection does not provide for payment or gifts to
respondents.
10. Assurance
of Confidentiality Provided to Respondents
FDA
proposed that a particular section (i.e., the "GRAS exemption
claim") of a notice be immediately available for public
disclosure on the date the notice is received. FDA also proposed
that all remaining data and information in a notice will become
available for public disclosure, in accordance with 21 CFR part 20,
on the date of receipt of the notice. The general recognition
standard signifies that neither the proposed use of the substance nor
the critical information needed to establish its safety are
confidential. Therefore, FDA presumes that a notice will not contain
any information that is protected from public disclosure. Moreover,
because a GRAS substance may be marketed without prior approval, FDA
presumes that, in most cases, submission of a notice will not reflect
the notifier's plans about the timing of commercialization, which is
arguably confidential commercial information (21 CFR 20.61(b)),
because a notifier may market a substance at any time before or after
notifying FDA.
12. Estimates
of Annualized Burden Hours and Costs
Description
of Respondents:
Manufacturers of substances used in food and feed.
FDA estimates the burden of this collection of information as follows:
21 CFR Section |
No. of Respondents |
Annual Frequency per Response |
Total Annual Responses |
Hours per Response |
Total Hours |
170.36 |
25 |
1 |
25 |
150 |
3,750 |
570.36 |
5 |
1 |
5 |
150 |
750 |
Total |
|
|
|
|
4,500 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
21 CFR Section |
No. of Recordkeepers |
Annual Frequency per Recordkeeping |
Total Annual Records |
Hours per Record |
Total Hours |
170.36(c)(v) |
25 |
1 |
25 |
15 |
375 |
570.36(c)(v) |
5 |
1 |
5 |
15 |
75 |
Total |
|
|
|
|
450 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In the proposed rule, FDA estimated that the Center for Food Safety and Applied Nutrition (CFSAN) would receive approximately 50 GRAS notices per year and that the Center for Veterinary Medicine (CVM) would receive approximately 10 GRAS notices per year. Although FDA requested comment on this estimate, the comments did not provide useful information regarding this issue. Therefore, FDA evaluated the number of notices received by CFSAN to date. CFSAN received 274 GRAS notices during the 11-year period from 1998 through 2008, for an average of approximately 25 GRAS notices per year. Based on this experience, FDA is revising its estimate of the annual number of GRAS notices submitted to CFSAN to be 25 or less. FDA also is revising its estimate of the annual number of GRAS notices submitted to CVM to be 5 or less.
Estimated Annualized Cost for the Burden Hours
FDA estimates the annualized burden hour cost to respondents for this collection of information to be approximately $426,096. FDA estimates a respondent’s average wage to be that of a Federal government employee at the GS-13/Step-2 rate for the Washington-Baltimore locality pay area for the year 2009, which is $43.04 per hour. To account for overhead, this cost is increased by 100 percent, which is $86.08 per hour. Thus, the annual wage cost for completion and submission of GRAS notifications is approximately $426,096 (4,950 hours x $86.08 per hour).
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection.
14. Annualized
Cost to Federal
Government
FDA
is estimating that the agency will direct approximately 4 full time
equivalent positions (FTE’s) to the GRAS notification procedure
for human foods. Due to the smaller number of notices anticipated
for animal food, only 1 FTE is expected to be devoted to processing
the notices submitted to CVM. Based on an average cost of $168,090
per fully supported position ($84,045 increased by 100 percent to
account for overhead), the cost of processing GRAS notifications
would be $840,450 per year ($168,090 x 5).
15. Explanation
for Program Changes or Adjustments
The
adjustment in burden is due to a decrease in the estimated number of
respondents. FDA lowered its estimate of the number of respondents
based on its experience with notices received from 1998 to 2008.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA
proposed to make readily accessible to the public the information in
a section of the notice called the “GRAS exemption claim”
and the agency's response to the notice. At this time, FDA is making
this information accessible through an electronic inventory of GRAS
notices [http://www.cfsan.fda.gov/~rdb/opa-gras.html]. The entire
GRAS notice is publicly available consistent with the Freedom of
Information Act and other federal disclosure statutes. In addition,
FDA posts on the agency’s Web site the complete text of
frequently requested GRAS notices (after removal of any trade secrets
or other confidential information) (at
http://www.cfsan.fda.gov/~prise/prisesum.html).
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There
are no reasons why display of the expiration date for OMB approval of
the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
N/A.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2009-04-17 |
| File Created | 2009-04-17 |