Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 47425-47427 [2022-16502]
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Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
between sleep, fatigue, fatigue
management, and related factors, within
the onshore OGE industry.
Primary data will be collected using
three approaches. First, researchers will
collect direct measurements of sleep
and alertness among OGE workers.
Second, researchers will use
questionnaires to collect information on
OGE worker demographics, occupation,
general heath, normal working hours,
commute times, home life, physical
sleeping environment, and typical sleep
quality. Third, researchers will collect
qualitative information through
interviews with workers, front-line
supervisors, health and safety leaders,
as well as subject matter experts, to
understand challenges and
opportunities related to fatigue
management in the OGE industry.
CDC requests OMB approval for an
estimated 305 annual burden hours.
There is no cost to respondents other
than their time to participate.
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Assessing Fatigue and Fatigue
Management in U.S. Onshore Oil and
Gas Extraction Industry—New—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Oil and gas extraction (OGE) workers
play an important role in supporting the
United States economy and help fulfill
the energy needs of Americans and
American businesses. OGE workers
have significant risks for a variety of
exposures at oil and gas well sites.
There has been no significant fatigue
research in the United States onshore
upstream OGE sector. This proposed
project will characterize relationships
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Total burden
(in hours)
Form name
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Land-based OGE workers ................
Field-level Supervisors ......................
Health and Safety Leaders ...............
Subject Matter Experts .....................
Baseline Questionnaire ....................
Daily Pre-Shift Questionnaires .........
Daily Post-Shift Questionnaires .......
Psychomotor Vigilance Test (PVT) ..
Worker Interview Guide ...................
Manager Interview Guide .................
HSE Interview Guide ........................
SME Interview Guide .......................
80
80
80
80
30
10
7
3
1
14
14
28
1
1
1
1
12/60
3/60
3/60
3/60
90/60
1
1
1
16
56
56
112
45
10
7
3
Total ...........................................
...........................................................
........................
........................
........................
305
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–16561 Filed 8–2–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondents
Product-Specific Guidances; Draft and
Revised Draft Guidances for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
18:39 Aug 02, 2022
Jkt 256001
announcing the availability of
additional draft and revised draft
product-specific guidances. The
guidances provide product-specific
recommendations on, among other
things, the design of bioequivalence
(BE) studies to support abbreviated new
drug applications (ANDAs). In the
Federal Register of June 11, 2010, FDA
announced the availability of a guidance
for industry entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website. The guidances
identified in this notice were developed
using the process described in that
guidance.
Submit either electronic or
written comments on the draft guidance
by October 3, 2022 to ensure that the
Agency considers your comment on this
DATES:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
draft guidance before it begins work on
the final version of the guidance.
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
E:\FR\FM\03AUN1.SGM
03AUN1
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Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices
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as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Product-Specific
Guidances; Draft and Revised Draft
Guidances for Industry.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
VerDate Sep<11>2014
18:39 Aug 02, 2022
Jkt 256001
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Christine Le, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4714, Silver Spring,
MD 20993–0002, 301–796–2398, PSGQuestions@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products’’ that explained the process
that would be used to make productspecific guidances available to the
public on FDA’s website at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
As described in that guidance, FDA
adopted this process as a means to
develop and disseminate productspecific guidances and provide a
meaningful opportunity for the public to
consider and comment on those
guidances. Under that process, draft
guidances are posted on FDA’s website
and announced periodically in the
Federal Register. The public is
encouraged to submit comments on
those recommendations within 60 days
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
of their announcement in the Federal
Register. FDA considers any comments
received and either publishes final
guidances or publishes revised draft
guidances for comment. Guidances were
last announced in the Federal Register
on May 20, 2022 (87 FR 30962). This
notice announces draft product-specific
guidances, either new or revised, that
are posted on FDA’s website.
II. Drug Products for Which New Draft
Product-Specific Guidances Are
Available
FDA is announcing the availability of
new draft product-specific guidances for
industry for drug products containing
the following active ingredients:
TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS
Active Ingredient(s)
Acetaminophen; Ibuprofen
Amphetamine; Amphetamine aspartate/Dextroamphetamine sulfate
Ampicillin/Ampicillin trihydrate
Azelastine hydrochloride
Berotralstat hydrochloride
Cabotegravir sodium
Carbamazepine
Caspofungin acetate
Cobicistat; Darunavir; Emtricitabine;
Tenofovir alafenamide fumarate
Cyclosporine
Cytarabine; Daunorubicin
Dasiglucagon hydrochloride
Doxycycline hyclate
Etonogestrel
Famotidine
Gallium Ga-68 gozetotide
Ibuprofen
Ketoprofen
Lonafarnib
Loperamide hydrochloride; Simethicone
Loteprednol etabonate
Mometasone furoate; Olopatadine hydrochloride
Nifurtimox
Pafolacianine sodium
Relugolix
Setmelanotide acetate
Technetium Tc-99m sodium pertechnetate
generator
Vericiguat
Vibegron
III. Drug Products for Which Revised
Draft Product-Specific Guidances Are
Available
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
Active Ingredient(s)
Amoxicillin; Clavulanate potassium
Azelastine hydrochloride
E:\FR\FM\03AUN1.SGM
03AUN1
Federal Register / Vol. 87, No. 148 / Wednesday, August 3, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Active Ingredient(s)
Cetirizine hydrochloride
Dantrolene sodium
Ethinyl estradiol; Norethindrone
Ethinyl estradiol; Norethindrone acetate
Lamotrigine
Lanthanum carbonate
Loratadine
Medroxyprogesterone acetate (multiple reference listed drugs)
Meloxicam
Methylphenidate hydrochloride
Nicotine
Olopatadine hydrochloride
Oxymetazone hydrochloride; Tetracaine hydrochloride
Prednisone
Tacrolimus
Upadacitinib
[Docket No. FDA–2022–N–0008]
Advisory Committee; Blood Products
Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
For a complete history of previously
published Federal Register notices
related to product-specific guidances, go
to https://www.regulations.gov and
enter Docket No. FDA–2007–D–0369.
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidances, when
finalized, will represent the current
thinking of FDA on, among other things,
the product-specific design of BE
studies to support ANDAs. They do not
establish any rights for any person and
are not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
The Food and Drug
Administration (FDA) is announcing the
renewal of the Blood Products Advisory
Committee by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
Blood Products Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the May 13, 2024,
expiration date.
DATES: Authority for the Blood Products
Advisory Committee will expire on May
13, 2024, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993–0002,
240–402–8054, Christina.Vert@
fda.hhs.gov.
IV. Paperwork Reduction Act of 1995
SUPPLEMENTARY INFORMATION:
FDA tentatively concludes that these
draft guidances contain no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
lotter on DSK11XQN23PROD with NOTICES1
Food and Drug Administration
Dated: July 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–16502 Filed 8–2–22; 8:45 am]
BILLING CODE 4164–01–P
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SUMMARY:
Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Blood Products Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology which are
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which the Food and Drug
Administration has regulatory
responsibility. The Committee also
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47427
advises the Commissioner of Food and
Drugs of its findings regarding screening
and testing (to determine eligibility) of
donors and labeling of the products, on
clinical and laboratory studies involving
such products, on the affirmation or
revocation of biological products
licenses, and on the quality and
relevance of FDA’s research program
which provides the scientific support
for regulating these agents. The
Committee will function at times as a
medical device panel under the Federal
Food, Drug, and Cosmetic Act Medical
Device Amendments of 1976. As such,
the Committee: (1) recommends
classification of devices subject to its
review into regulatory categories; (2)
recommends the assignment of a
priority for the application of regulatory
requirements for devices classified in
the standards or premarket approval
category; (3) advises on formulation of
product development protocols and
reviews premarket approval
applications for those devices to
recommend changes in classification as
appropriate; (4) recommends exemption
of certain devices from the application
of portions of the Medical Device
Amendments of 1976; (5) advises on the
necessity to ban a device; and (6)
responds to requests from the Agency to
review and make recommendations on
specific issues or problems concerning
the safety and effectiveness of devices.
The Committee shall consist of a core
of 17 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of clinical
and administrative medicine,
hematology, immunology, blood
banking, surgery, internal medicine,
biochemistry, engineering, biological
and physical sciences, biotechnology,
computer technology, statistics,
epidemiology, sociology/ethics, and
other related professions. Members will
be invited to serve for overlapping terms
of up to 4 years. Non-Federal members
of this committee will serve as Special
Government Employees,
representatives, or Ex-Officio members.
Federal members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Pages 47425-47427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16502]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.
DATES: Submit either electronic or written comments on the draft
guidance by October 3, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such
[[Page 47426]]
as a manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Christine Le, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, 301-
796-2398, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on May 20, 2022 (87 FR 30962). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's website.
II. Drug Products for Which New Draft Product-Specific Guidances Are
Available
FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:
Table 1--New Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
Active Ingredient(s)
-------------------------------------------------------------------------
Acetaminophen; Ibuprofen
Amphetamine; Amphetamine aspartate/Dextroamphetamine sulfate
Ampicillin/Ampicillin trihydrate
Azelastine hydrochloride
Berotralstat hydrochloride
Cabotegravir sodium
Carbamazepine
Caspofungin acetate
Cobicistat; Darunavir; Emtricitabine; Tenofovir alafenamide fumarate
Cyclosporine
Cytarabine; Daunorubicin
Dasiglucagon hydrochloride
Doxycycline hyclate
Etonogestrel
Famotidine
Gallium Ga-68 gozetotide
Ibuprofen
Ketoprofen
Lonafarnib
Loperamide hydrochloride; Simethicone
Loteprednol etabonate
Mometasone furoate; Olopatadine hydrochloride
Nifurtimox
Pafolacianine sodium
Relugolix
Setmelanotide acetate
Technetium Tc-99m sodium pertechnetate generator
Vericiguat
Vibegron
------------------------------------------------------------------------
III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available
FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:
------------------------------------------------------------------------
Active Ingredient(s)
-------------------------------------------------------------------------
Amoxicillin; Clavulanate potassium
Azelastine hydrochloride
[[Page 47427]]
Cetirizine hydrochloride
Dantrolene sodium
Ethinyl estradiol; Norethindrone
Ethinyl estradiol; Norethindrone acetate
Lamotrigine
Lanthanum carbonate
Loratadine
Medroxyprogesterone acetate (multiple reference listed drugs)
Meloxicam
Methylphenidate hydrochloride
Nicotine
Olopatadine hydrochloride
Oxymetazone hydrochloride; Tetracaine hydrochloride
Prednisone
Tacrolimus
Upadacitinib
------------------------------------------------------------------------
For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
IV. Paperwork Reduction Act of 1995
FDA tentatively concludes that these draft guidances contain no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
V. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: July 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16502 Filed 8-2-22; 8:45 am]
BILLING CODE 4164-01-P
