82 FR 58004 - 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Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 235 (December 8, 2017)

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of October 3, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments.

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 58004-58005]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26436]


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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Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; 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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the notice of availability that appeared in the 
Federal Register of October 3, 2017. In the notice of availability, FDA 
requested comments on the draft guidance for industry entitled ``ANDAs 
for Certain Highly Purified Synthetic Peptide Drug Products That Refer 
to Listed Drugs of rDNA Origin.'' The Agency is taking this action in 
response to public interest in the draft guidance and to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of 
availability published October 3, 2017 (82 FR 46075). Submit either 
electronic or written comments on the draft guidance by February 4, 
2018, to ensure that the Agency considers your comment on this draft 
guidance before it begins work on the final version of the guidance.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

[[Page 58005]]

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 ``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.'' 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.
     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.thefederalregister.org/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.

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. 75, Rm. 1672, Silver 
Spring, MD 20993-0002, 301-796-9291, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 3, 2017, 
FDA published a notice of availability with a 60-day comment period to 
request comments on the draft guidance for industry entitled ``ANDAs 
for Certain Highly Purified Synthetic Peptide Drug Products That Refer 
to Listed Drugs of rDNA Origin.''
    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.
    Based on public interest in the draft guidance, FDA is extending 
the comment period for the notice of availability for 60 days, until 
February 4, 2018. The Agency believes that a 60-day extension allows 
adequate time for interested persons to submit comments without 
significantly delaying guidance on these important issues.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26436 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P