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Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability, 46075-46076 [2017-21202]
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
46075
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
New requests to be placed on the lists ...................
Biennial update ........................................................
Occasional updates .................................................
2,000
2,000
200
1
1
1
2,000
2,000
200
1 ................................
0.5 (30 minutes) ........
0.5 (30 minutes) ........
2,000
1,000
100
Total ..................................................................
........................
........................
........................
....................................
3,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA bases its estimate on the number
of manufacturers/processors that have
submitted new written requests,
biennial updates, and occasional
updates over the past 10 years. The
estimate of the number of burden hours
it will take a manufacturer/processor to
gather the information needed to be
placed on the list or update its
information is based on FDA’s
experience with manufacturers/
processors submitting similar requests.
FDA believes that the information to be
submitted will be readily available to
manufacturers/processors. This
collection is also incorporating
information collected to maintain lists
of eligible exporters of dairy products
who wish to export to the EU from OMB
control number 0910–0320, ‘‘Request for
Information from U.S. Processors that
Export to the European Community.’’
FDA estimates that 2,000 firms will
average 60 minutes (1 hour) to submit
new requests for inclusion on the list,
2,000 firms will average 30 minutes (0.5
hour) to update their information every
2 years, and 200 firms will average 30
minutes (0.5 hour) to occasionally
update their information in this system.
We also believe that submission via the
electronic registry system will not affect
the burden estimates. An electronic
registry will enhance the ability of firms
to more efficiently request inclusion on
export lists. FDA calculates, therefore,
that the total burden for this collection
is 3,100 hours ((2,000 × 1) plus (2,000
× 0.5) plus (200 × 0.5)).
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21212 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
16:49 Oct 02, 2017
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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.
E:\FR\FM\03OCN1.SGM
03OCN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
46076
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
• 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/201523389.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.
Gail
Schmerfeld, Office of Generic Drugs,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
Ave., Bldg. 1672, Silver Spring, MD
20993–0002, 301–796–9291.
SUPPLEMENTARY INFORMATION:
requirements of the applicable statutes
and regulations. This draft guidance is
not subject to Executive Order 12866.
I. Background
II. The Paperwork Reduction Act of
1995
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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/Guidance
ComplianceRegulatoryInformation/
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4918]
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. The
general function of the committee is to
provide advice and recommendations to
the Agency on FDA’s regulatory issues.
The meeting will be open to the public.
FDA is establishing a docket for public
comment on this document.
SUMMARY:
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[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