Document ID: FDA-2017-N-0366-0015
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Food and Drug Administration Advisory Committee Regulations
Posted Date: 2023-06-29T04:00Z

[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42079-42080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13863]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0366]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration Advisory Committee Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by July 31, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0833. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

FDA Advisory Committee Regulations

OMB Control No. 0910-0833--Revision

    This information collection helps support implementation of FDA 
regulations found in part 14 (21 CFR part 14). These regulations govern 
procedures applicable to presenting information and views before an FDA 
advisory committee in accordance with the Federal Advisory Committee 
Act (FACA) (5 U.S.C. App. 2 and 3, Pub. L. 92-463). FACA is designed to 
assure that Congress and the public are kept informed with respect to 
the purpose, membership, and activities of advisory committees. It does 
not specify the manner in which advisory committee members and staff 
must be appointed.
    Public advisory committee regulations in part 14 set forth 
requirements governing the administrative procedures to follow for the 
operation of advisory committees. Agency regulations in part 14, 
subpart A (Sec. Sec.  14.1 through 14.15) identify scope of coverage, 
applicable definitions, and establish general provisions. The 
regulations in part 14, subpart B (Sec. Sec.  14.20 through 14.39) set 
forth content and format requirements along with required schedules for 
submission of information. The regulations in part 14 subparts C, D, 
and E (Sec. Sec.  14.40 through 14.95) set forth requirements governing 
advisory committee establishment, recordkeeping, and maintenance, 
respectively.
    FDA will also require that nominees to serve on advisory committees 
submit a consent form authorizing FDA to post, without removing or 
redacting any information, to FDA's public website (http://www.fda.gov/AdvisoryCommittees) the curriculum vitae (CV) submitted as part of 
their nomination materials if the nominee is selected to serve on an 
advisory committee. The consent form requires that the nominee affirm 
that the CV does not include any confidential information, including 
information pertaining to third parties, that the nominee is not 
permitted to disclose. A nominee will be required to submit a signed 
consent form as a part of the nomination package for the nomination to 
be considered complete.
    All nominations for new advisory committee members will be required 
to be submitted through FDA's website at http://accessdata.test.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any 
successor system, and the submission will be required to be accompanied 
by the consent form, on or after the date of OMB approval for this 
information collection. Although we are developing collection 
instruments, as communicated on our website, respondents may submit 
information to: Advisory Committee Oversight and Management Staff, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Silver Spring, MD 20993, 800-741-8138 or 301-
443-0572.
    In the Federal Register of February 13, 2023 (88 FR 9294), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received but were not 
responsive to the information collection topics solicited under the 
PRA. On our own initiative, we are clarifying the scope of coverage for 
the information collections.
    We estimate the burden of the collection of information as follows:

[[Page 42080]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                 Number of
       21 CFR part 14            Number of     responses per   Total annual     Average  burden     Total hours
                                respondents     respondent       responses       per  response
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                                    Subpart E--Members of Advisory Committees
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Advisory Committee                       308               1             308  0.25 (15 minutes).              77
 Membership Nominations.
Member Submission of Updated             452               1             452  0.25 (15 minutes).             113
 Information.
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    Total...................  ..............  ..............  ..............  ..................             190
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13863 Filed 6-28-23; 8:45 am]
BILLING CODE 4164-01-P