[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46075-46076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21202]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5767]
Abbreviated New Drug Applications for Certain Highly Purified
Synthetic Peptide Drug Products That Refer to Listed Drugs of
Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled ``ANDAs for
Certain Highly Purified Synthetic Peptide Drug Products That Refer to
Listed Drugs of rDNA Origin.'' The Federal Food, Drug, and Cosmetic Act
(FD&C Act) permits any person to submit to the FDA an abbreviated new
drug application (ANDA) to seek approval to market a generic version of
a previously approved drug product. This draft guidance is intended to
assist potential applicants in determining when an application for a
synthetic peptide drug product (specifically glucagon, liraglutide,
nesiritide, teriparatide, and teduglutide) that refers to a previously
approved peptide drug product of recombinant deoxyribonucleic acid
(rDNA) origin should be submitted as an ANDA rather than as new drug
application (NDA).
DATES: Submit either electronic or written comments on the draft
guidance by December 4, 2017 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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-2017-D-5767 for ``ANDAs for Certain Highly Purified Synthetic
Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.''
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.
[[Page 46076]]
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 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.gpo.gov/fdsys/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.
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: Gail Schmerfeld, Office of Generic
Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1672, Silver Spring, MD
20993-0002, 301-796-9291.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug
Products That Refer to Listed Drugs of rDNA Origin.'' In general, for
FDA to approve an ANDA submitted under section 505(j) of the FD&C Act,
an ANDA applicant must demonstrate, among other things, that the
proposed generic drug has the ``same'' active ingredient(s) as and is
bioequivalent to its reference listed drug, and that the methods used
in, and the facilities and controls used for, the manufacture,
processing, and packing of the proposed generic drug are adequate to
assure and preserve its identity, strength, quality, and purity
(sections 505(j)(2)(A) and (4) (21 U.S.C. 355(j)(2)(A) and (4)) of the
FD&C Act). If a person is seeking approval of a synthetic peptide drug
product (specifically glucagon, liraglutide, nesiritide, teriparatide,
or teduglutide) and intends to submit an application that refers to a
previously approved peptide drug product of rDNA origin, if the active
ingredient in the proposed synthetic peptide drug product can be shown
to be the same as the active ingredient in the peptide drug product of
rDNA origin, whether the application should be submitted as an ANDA
under section 505(j) of the FD&C Act or as a new drug application under
section 505(b) of the FD&C Act will depend largely on the impurity
profile for the synthetic peptide drug product as compared to the
impurity profile for the peptide drug product of rDNA origin.
Differences in impurities, particularly peptide-related impurities, may
affect the safety or effectiveness of a peptide drug product. This
draft guidance is intended to assist potential applicants in
determining when an application for a synthetic peptide drug product
that refers to a previously approved peptide drug product of rDNA
origin should be submitted as an ANDA rather than an NDA.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the submission
of ANDAs for certain highly purified synthetic peptide drug products
that refer to listed drugs of rDNA origin. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This draft guidance is not subject
to Executive Order 12866.
II. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information required under 21 CFR part 314 for
the submission of NDAs and ANDAs is approved under OMB control number
0910-0001, and the submission of controlled correspondence pertaining
to ANDAs is approved under OMB control number 0910-0797.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21202 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P