[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]


-----------------------------------------------------------------------

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Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; 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.

-----------------------------------------------------------------------

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the availability of a draft guidance for industry entitled ``ANDAs for 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 This draft guidance is intended to 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DATES: Submit either electronic or written comments on the draft 
guidance by December 4, 2017 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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