Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committee Regulations, 42079-42080 [2023-13863]
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
response, recordkeeping, and disclosure
are based on our experience with the
pilot program.
Our estimated burden for the
information collection reflects an
overall decrease of 3,129 hours and an
increase of 94 responses/records. We
attribute this adjustment to a decrease in
the one-time burden for accreditation
bodies and testing laboratories training
and SOPs because much of this activity
was completed during the pilot. In
addition, there is an increase in the
annual responses/records because there
is an increase in renewal requests (by
accreditation bodies to continue ASCA
Recognition and by testing laboratories
to continue ASCA Accreditation) since
the pilot program was initiated.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13860 Filed 6–28–23; 8:45 am]
BILLING CODE 4164–01–P
FDA Advisory Committee Regulations
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.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Jun 28, 2023
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, PRAStaff@
fda.hhs.gov.
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.
Jkt 259001
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 (§§ 14.1 through 14.15)
identify scope of coverage, applicable
definitions, and establish general
provisions. The regulations in part 14,
subpart B (§§ 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
PO 00000
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Fmt 4703
Sfmt 4703
42079
E (§§ 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
(https://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
https://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:
E:\FR\FM\29JNN1.SGM
29JNN1
42080
Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR part 14
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Subpart E—Members of Advisory Committees
Advisory Committee Membership Nominations ..................
308
1
308
Member Submission of Updated Information ......................
452
1
452
Total ..............................................................................
........................
........................
........................
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2016–N–2474]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; New Animal Drugs
for Minor Use and Minor Species
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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.
SUMMARY:
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 0910–0605. Also include
the FDA docket number found in
brackets in the heading of this
document.
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:21 Jun 28, 2023
Jkt 259001
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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.
New Animal Drugs for Minor Use and
Minor Species
Food and Drug Administration
ACTION:
........................
77
113
190
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.
AGENCY:
0.25 (15 minutes).
0.25 (15 minutes).
OMB Control Number 0910–0605—
Revision
This information collection supports
FDA regulations that implement
sections 572 and 573 of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360ccc–1 and 21 U.S.C.
360ccc–2) which establish an index of
legally marketed unapproved new
animal drugs for minor species and
requirements for the designation of
minor use or minor species new animal
drugs, respectively. Agency regulations
are codified in part 516 (21 CFR part
516) and include recordkeeping and
reporting requirements. The purpose of
these regulations is to encourage the
development of these new animal drugs,
while still ensuring appropriate
safeguards for animal and human
health. The general provisions in part
516, subpart A, set forth its purpose,
scope, and applicable definitions.
Our regulations in part 516, subpart B,
provide for designation status for Minor
Use and Minor Species (MUMS) drugs
prior to their approval or conditional
approval. MUMS-drug designation
makes the sponsor eligible for
incentives to support the approval or
conditional approval of the designated
use and is completely optional for drug
sponsors. The regulations describe how
to apply for designation, what needs to
be submitted, and other information
pertaining to this option. Sponsors of
designated new animal drugs are
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Frm 00040
Fmt 4703
Sfmt 4703
required to demonstrate due diligence
toward approval or conditional approval
through submission of annual reports
documenting their progress for each
designated use. We use this information
to allow for determining eligibility for
designation and the associated
incentives and benefits, including a
7-year period of exclusive marketing
rights, as provided by section 573 of the
FD&C Act. It enables us to process
requests for MUMS-drug designation,
requests to amend MUMS-drug
designation, changes in sponsorship,
termination of MUMS-drug designation,
requirements for annual reports from
sponsors, and provisions for insufficient
quantities of MUMS-designated drugs.
Regulations in part 516, subpart C, are
intended to make more medications
legally available to veterinarians and
animal owners for the treatment of
minor animal species. In some cases, a
minor species drug is intended for use
in species that are too rare or too varied
to be the subject of adequate and wellcontrolled studies in support of a drug
approval. In such cases, FDA may add
the drug to the public index listing of
legally marketed unapproved new
animal drugs for minor species animals
(Index), as provided for by section 572
of the FD&C Act. Within limitations
established by the statute, such indexing
provides a basis for legally marketing an
unapproved new animal drug intended
for use in a minor species. Our
regulations in part 516, subpart C,
specify, among other things, the criteria
and procedures for requesting eligibility
for indexing and for requesting addition
to the Index, as well as the annual
reporting requirements for holders of an
index listing. The administrative
procedures and criteria for indexing a
new animal drug for use in a minor
species, as well as modifications and
removal of a drug from the Index are
also set forth. FDA uses the information
for the activities described above.
In the Federal Register of August 1,
2022 (87 FR 46961), FDA published a
60-day notice requesting public
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 (https://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 https://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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR part 14 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Subpart E--Members of Advisory Committees
----------------------------------------------------------------------------------------------------------------
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.
-----------------------------------------------------------------------------------
Total................... .............. .............. .............. .................. 190
----------------------------------------------------------------------------------------------------------------
\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
