Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability, 69278-69280 [2022-25210]
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69278
Federal Register / Vol. 87, No. 222 / Friday, November 18, 2022 / Notices
of Respondents: 7; Total Annual
Responses: 2; Total Annual Hours: 140.
(For policy questions regarding this
collection contact Angela Cimino at
410–786–2638.)
Dated: November 15, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–25162 Filed 11–17–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Generic Clearance for
Reviewer Recruitment Forms
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
SUMMARY: The Administration for
Children and Families (ACF) proposes
to extend approval of the existing
overarching generic clearance for
Reviewer Recruitment Forms (Office of
Management and Budget (OMB) #0970–
0477). No changes are proposed to the
terms of the overarching generic.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act (PRA) of 1995, ACF is
soliciting public comments on the
specific aspects of the information
collection described above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
opreinfocollection@acf.hhs.gov. Identify
all requests by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: The overarching generic
clearance for Reviewer Recruitment
Forms provides ACF with the
opportunity to collect from potential
reviewers, such as those who review
grant proposals, conference proposals,
research/evaluation plans, study
designs, report drafts, and/or other ACF
materials.
ACF developed this generic because
each program office and within ACF has
slightly different needs for information
about reviewer applicants based on the
specific activities for which reviewers
are needed, yet the individual forms
submitted under the generic will serve
an identical function. The overarching
purpose is to select qualified reviewers
for ACF review processes and activities
based on professional qualifications.
Information will be collection through
questions on forms and documents
provided by candidates. Example
documents include writing samples and
curriculum vitae and/or resume. ACF
uses the information collected to recruit
well-qualified reviewers with relevant
background experience and knowledge.
The abbreviated clearance process of
the generic clearance allows program
offices to gather a suitable pool of
candidates within the varied time
periods available for reviewer
recruitment.
These forms submitted under this
generic will be voluntary, low-burden
and uncontroversial.
Respondents: Individuals who may
apply to review materials for ACF.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
(total over
request
period)
Number of
responses per
respondent
(total over
request
period)
Avg. burden
per response
(in hours)
Total burden
(in hours)
Reviewer Recruitment Form ............................................................................
3,000
1
.5
1,500
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–25202 Filed 11–17–22; 8:45 am]
BILLING CODE 4184–79–P
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16:46 Nov 17, 2022
Jkt 259001
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
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 January 17, 2023 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:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
E:\FR\FM\18NON1.SGM
18NON1
Federal Register / Vol. 87, No. 222 / Friday, November 18, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
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
VerDate Sep<11>2014
16:46 Nov 17, 2022
Jkt 259001
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-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, 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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
69279
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
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 August 3, 2022 (87 FR 47425). 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)
Ammonium lactate (multiple reference listed
drugs).
Budesonide.
Calcitonin salmon.
Clindamycin phosphate.
Deferiprone.
Drospirenone; Estetrol.
Eteplirsen.
Fidaxomicin.
Fosdenopterin hydrobromide.
Hydrocortisone.
Hydroxyurea.
Inotersen sodium.
Ketotifen fumarate.
Magnesium sulfate; Potassium chloride; Sodium sulfate.
Melphalan flufenamide hydrochloride.
Miconazole nitrate; White petrolatum; Zinc
oxide.
Mometasone furoate.
Nicardipine hydrochloride.
Omeprazole magnesium.
Patisiran sodium.
Ponesimod.
Ranolazine.
Tepotinib hydrochloride.
Tivozanib hydrochloride.
Triamcinolone acetonide.
Trilaciclib dihydrochloride.
Varenicline tartrate.
Voclosporin.
III. Drug Products for Which Revised
Draft Product-Specific Guidances Are
Available
FDA is announcing the availability of
revised draft product-specific guidances
E:\FR\FM\18NON1.SGM
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69280
Federal Register / Vol. 87, No. 222 / Friday, November 18, 2022 / Notices
Dated: November 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
for industry for drug products
containing the following active
ingredients:
TABLE 2—REVISED DRAFT PRODUCTSPECIFIC GUIDANCES FOR DRUG
PRODUCTS
Acyclovir.
Baricitinib.
Calcium carbonate; Famotidine; Magnesium
hydroxide.
Daunorubicin citrate.
Deferiprone.
Ethinyl estradiol; Norethindrone acetate.
Ferric oxyhydroxide (multiple reference listed
drugs).
Goserelin acetate (multiple reference listed
drugs).
Icosapent ethyl.
Lapatinib ditosylate.
Lidocaine.
Oxycodone.
Progesterone.
Ranolazine.
Rifaximin.
Sodium phosphate, dibasic, anhydrous; Sodium phosphate, monobasic, monohydrate.
Sumatriptan succinate (multiple product-specific guidances).
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.
khammond on DSKJM1Z7X2PROD with NOTICES
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.
16:46 Nov 17, 2022
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Active ingredient(s)
VerDate Sep<11>2014
[FR Doc. 2022–25210 Filed 11–17–22; 8:45 am]
Jkt 259001
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Member Conflict.
Date: December 2, 2022.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2131B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Jolanta Maria Topczewska,
Ph.D., Scientific Review Branch, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, National
Institute Health, 6710B Rockledge Drive,
Room 2131B, Bethesda, MD 20892, (301)
451–0000, jolanta.topczewska@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Capstone Centers for
Multidisciplinary Research in Child Abuse
and Neglect.
Date: December 8–9, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2137C, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Kimberly L. Houston, MD,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health & Human
Development, National Institute Health,
6710B Rockledge Drive, Room 2137C,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Bethesda, MD 20892, (301) 827–4902,
kimberly.houston@nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Program Project
Grants for HIV Research.
Date: December 13–14, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, 6710B
Rockledge Drive, Room 2121B, Bethesda, MD
20892–7510 (Virtual Meeting).
Contact Person: Christiane M. Robbins,
Scientific Review Officer, Scientific Review
Branch, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institute Health,
6710B Rockledge Drive, Room 2121B,
Bethesda, MD 20817, (301) 451–4989,
crobbins@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.865, Research for Mothers
and Children, National Institutes of Health,
HHS)
Dated: November 14, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25165 Filed 11–17–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cardiovascular Sciences.
Date: December 7, 2022.
Time: 8:00 a.m. to 12:00 p.m.
E:\FR\FM\18NON1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Notices]
[Pages 69278-69280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25210]
-----------------------------------------------------------------------
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, Department of Health and Human
Services (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 January 17, 2023 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.
[[Page 69279]]
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 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, 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 August 3, 2022 (87 FR 47425). 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)
-------------------------------------------------------------------------
Ammonium lactate (multiple reference listed drugs).
Budesonide.
Calcitonin salmon.
Clindamycin phosphate.
Deferiprone.
Drospirenone; Estetrol.
Eteplirsen.
Fidaxomicin.
Fosdenopterin hydrobromide.
Hydrocortisone.
Hydroxyurea.
Inotersen sodium.
Ketotifen fumarate.
Magnesium sulfate; Potassium chloride; Sodium sulfate.
Melphalan flufenamide hydrochloride.
Miconazole nitrate; White petrolatum; Zinc oxide.
Mometasone furoate.
Nicardipine hydrochloride.
Omeprazole magnesium.
Patisiran sodium.
Ponesimod.
Ranolazine.
Tepotinib hydrochloride.
Tivozanib hydrochloride.
Triamcinolone acetonide.
Trilaciclib dihydrochloride.
Varenicline tartrate.
Voclosporin.
------------------------------------------------------------------------
III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available
FDA is announcing the availability of revised draft product-
specific guidances
[[Page 69280]]
for industry for drug products containing the following active
ingredients:
Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
Active ingredient(s)
-------------------------------------------------------------------------
Acyclovir.
Baricitinib.
Calcium carbonate; Famotidine; Magnesium hydroxide.
Daunorubicin citrate.
Deferiprone.
Ethinyl estradiol; Norethindrone acetate.
Ferric oxyhydroxide (multiple reference listed drugs).
Goserelin acetate (multiple reference listed drugs).
Icosapent ethyl.
Lapatinib ditosylate.
Lidocaine.
Oxycodone.
Progesterone.
Ranolazine.
Rifaximin.
Sodium phosphate, dibasic, anhydrous; Sodium phosphate, monobasic,
monohydrate.
Sumatriptan succinate (multiple product-specific guidances).
------------------------------------------------------------------------
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: November 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25210 Filed 11-17-22; 8:45 am]
BILLING CODE 4164-01-P
