[Federal Register Volume 91, Number 144 (Wednesday, July 29, 2026)]
[Notices]
[Pages 47834-47835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-15285]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Revised Draft Guidances for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional revised draft product-specific
guidances. The draft 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 draft 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DATES: Submit either electronic or written comments on the draft
guidance by September 28, 2026 to ensure that the Agency considers your
comment on these draft guidances before it begins work on the final
version of these guidances.
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 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; 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://
[[Page 47835]]
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: Joseph Kotsybar, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4714, Silver Spring, MD 20993-0002, [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 titled
``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 22, 2026 (91 FR 30307). This notice
announces revised draft product-specific guidances that are posted on
FDA's website.
FDA is also withdrawing the guidance for industry entitled ``ANDAs
for Certain Highly Purified Synthetic Peptide Drug Products That Refer
to Listed Drugs of rDNA Origin'' (May 2021) as it no longer reflects
FDA's current scientific thinking. As noted in the Center for Drug
Evaluation and Research guidance agenda, FDA plans to revise and
reissue the guidance this year.
II. 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:
Table 1--Revised Draft Product-Specific Guidances for Drug Products
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Active ingredient(s)
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Calcitonin salmon (multiple reference listed drugs).
Dasiglucagon hydrochloride.
Glucagon (multiple reference listed drugs).
Liraglutide (multiple reference listed drugs).
Pegcetacoplan (multiple reference listed drugs).
Semaglutide (multiple reference listed drugs).
Teriparatide (multiple reference listed drugs).
Tirzepatide (multiple reference listed drugs).
Vosoritide.
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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.
As we develop any final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
II. Paperwork Reduction Act of 1995
While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 312 for investigational new drugs have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 for applications for FDA approval to market a new drug and in 21
CFR part 320 for bioavailability and BE requirements have been approved
under OMB control number 0910-0001.
III. 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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-15285 Filed 7-28-26; 8:45 am]
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