Agency Information Collection Request; 30-Day Public Comment Request, 2617-2618 [2022-00760]
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices
MD 20993–0002, 301–796–8363,
stacy.kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) Has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PEPCID (famotidine) tablet, 20 mg and
40 mg, is the subject of NDA 019462,
held by Valeant Pharmaceuticals North
America LLC, and initially approved on
October 15, 1986. PEPCID is indicated
in adult and pediatric patients 40
kilograms and greater for the treatment
of active duodenal ulcer (DU), active
gastric ulcer, symptomatic nonerosive
gastroesophageal reflux disease (GERD),
erosive esophagitis due to GERD,
diagnosed by biopsy. PEPCID is
indicated in adults for the treatment of
pathological hypersecretory conditions
(e.g., Zollinger-Ellison syndrome,
multiple endocrine neoplasias) and
reduction of the risk of DU recurrence.
PEPCID (famotidine) tablet, 20 mg and
40 mg, is currently listed in the
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‘‘Discontinued Drug Product List’’
section of the Orange Book.
Zydus Pharmaceuticals (USA) Inc.
submitted a citizen petition dated
August 3, 2021 (Docket No. FDA–2021–
P–0885), under 21 CFR 10.30,
requesting that the Agency determine
whether PEPCID (famotidine) tablet, 20
mg and 40 mg, was withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PEPCID (famotidine)
tablet, 20 mg and 40 mg, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that PEPCID (famotidine)
tablet, 20 mg and 40 mg, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
PEPCID (famotidine) tablet, 20 mg and
40 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PEPCID (famotidine)
tablet, 20 mg and 40 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: January 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–00832 Filed 1–14–22; 8:45 am]
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2617
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0007]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 17, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Joseph Raborn joseph.raborn@hhs.gov
or (202) 870–2037. When submitting
comments or requesting information,
please include the document identifier
4040–0007–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Assurances for
Non-Construction Programs (SF–424B).
Type of Collection: Renewal.
OMB No.: 4040–0007.
Abstract: Assurances for NonConstruction Programs (SF–424B) is
used by applicants to apply for Federal
financial assistance. The Assurances for
Non-Construction Programs (SF–424B)
form requests that the applicants certify
specified required assurances as part of
their grant proposals. This form is
evaluated by Federal agencies as part of
the overall grant application. This IC
expires on February 28, 2022.
SUMMARY:
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2618
Federal Register / Vol. 87, No. 11 / Tuesday, January 18, 2022 / Notices
Grants.gov seeks a three-year clearance
of these collections.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
Grant Applicant ................................................................................................
1
9,772
0.5
4,886
Total ..........................................................................................................
1
9,772
0.5
4,886
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–00760 Filed 1–14–22; 8:45 am]
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0009]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 17, 2022.
SUMMARY:
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Assurances for
Construction Programs.
Type of Collection: Renewal.
OMB No.: 4040–0009.
Abstract: Assurances for Construction
Programs (SF–424D) is used by
applicants to apply for Federal financial
assistance. The Assurances for
Construction Programs (SF–424D) form
allows the applicants to provide specific
assurances as part of their grant
proposals. This form is evaluated by
Federal agencies as part of the overall
grant application. This IC expires on
February 28, 2022. Grants.gov seeks a
three-year clearance of these collections.
Type of respondent: Grant Applicant
and Awardee.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Joseph Raborn, joseph.raborn@hhs.gov
or (202) 870–2037. When submitting
comments or requesting information,
please include the document identifier
4040–0009–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
Grant-seeking organizations ............................................................................
353
1
.5
176.5
Total ..........................................................................................................
353
1
.5
176.5
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–00761 Filed 1–14–22; 8:45 am]
BILLING CODE 4151–AE–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0006]
Agency Information Collection
Request; 30-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
VerDate Sep<11>2014
17:00 Jan 14, 2022
Jkt 256001
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 17, 2022.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Joe
Raborn, joseph.raborn@hhs.gov or (202)
870–2037. When submitting comments
or requesting information, please
include the document identifier 4040–
0006–30D and project title for reference.
FOR FURTHER INFORMATION CONTACT:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 87, Number 11 (Tuesday, January 18, 2022)]
[Notices]
[Pages 2617-2618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-4040-0007]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before February 17,
2022.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Joseph Raborn [email protected] or
(202) 870-2037. When submitting comments or requesting information,
please include the document identifier 4040-0007-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Assurances for Non-Construction Programs
(SF-424B).
Type of Collection: Renewal.
OMB No.: 4040-0007.
Abstract: Assurances for Non-Construction Programs (SF-424B) is
used by applicants to apply for Federal financial assistance. The
Assurances for Non-Construction Programs (SF-424B) form requests that
the applicants certify specified required assurances as part of their
grant proposals. This form is evaluated by Federal agencies as part of
the overall grant application. This IC expires on February 28, 2022.
[[Page 2618]]
Grants.gov seeks a three-year clearance of these collections.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Grant Applicant................................. 1 9,772 0.5 4,886
---------------------------------------------------------------
Total....................................... 1 9,772 0.5 4,886
----------------------------------------------------------------------------------------------------------------
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2022-00760 Filed 1-14-22; 8:45 am]
BILLING CODE 4151-AE-P
