[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