83 FR 1618 - Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application; Draft Guidance for Industry; Availability; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 9 (January 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 9 (January 12, 2018)
| Page Range | 1618-1619 | |
| FR Document | 2018-00405 |
[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)] [Notices] [Pages 1618-1619] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00405] [[Page 1618]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5974] Determining Whether To Submit an Abbreviated New Drug Application or 505(b)(2) Application; Draft Guidance for Industry; Availability; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of October 13, 2017. In that document, FDA requested comments on the draft guidance for industry entitled ``Determining Whether to Submit an ANDA or 505(b)(2) Application.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the notice of availability published October 13, 2017 (82 FR 47749). Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 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-5974 for ``Determining Whether to Submit an ANDA or 505(b)(2) Application; Draft Guidance 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. 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. 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: Elizabeth Giaquinto Friedman, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 13, 2017, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry entitled ``Determining Whether to Submit an ANDA or 505(b)(2) Application.'' 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 factors for applicants to consider when determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act is appropriate for the submission of a marketing application to FDA. 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 guidance is not subject to Executive Order 12866. The Agency has received a request for a 30-day extension of the comment period for the draft guidance. The request conveyed concern that the requestor did not have sufficient time to develop a meaningful or thoughtful response to the draft guidance. [[Page 1619]] FDA has considered the request and is reopening the comment period for the draft guidance for 30 days, until February 12, 2018. The Agency believes that a 30-day reopening of the comment period allows adequate time for interested persons to submit comments to ensure that the Agency can consider the comments on this draft guidance before it begins work on the final version of the guidance. II. 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: January 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00405 Filed 1-11-18; 8:45 am] BILLING CODE 4164-01-P
![1618 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices
DEPARTMENT OF HEALTH AND public, submit the comment as a Docket: For access to the docket to
HUMAN SERVICES written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Food and Drug Administration Submissions’’ and ‘‘Instructions’’). received, go to https://
[Docket No. FDA–2017–D–5974] www.regulations.gov and insert the
Written/Paper Submissions
docket number, found in brackets in the
Determining Whether To Submit an Submit written/paper submissions as heading of this document, into the
Abbreviated New Drug Application or follows: ‘‘Search’’ box and follow the prompts
505(b)(2) Application; Draft Guidance • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
for Industry; Availability; Reopening of written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
the Comment Period Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
HHS. • For written/paper comments 10.115(g)(5)).
ACTION: Notice of availability; reopening submitted to the Dockets Management Submit written requests for single
of the comment period. Staff, FDA will post your comment, as copies of the draft guidance to the
well as any attachments, except for Division of Drug Information, Center for
SUMMARY: The Food and Drug information submitted, marked and Drug Evaluation and Research, Food
Administration (FDA or the Agency) is identified, as confidential, if submitted and Drug Administration, 10001 New
reopening the comment period for the as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
notice of availability, published in the Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
Federal Register of October 13, 2017. In must include the Docket No. FDA– 0002. Send one self-addressed adhesive
that document, FDA requested 2017–D–5974 for ‘‘Determining Whether label to assist that office in processing
comments on the draft guidance for to Submit an ANDA or 505(b)(2) your requests. See the SUPPLEMENTARY
industry entitled ‘‘Determining Whether Application; Draft Guidance for INFORMATION section for electronic
to Submit an ANDA or 505(b)(2) Industry.’’ Received comments will be access to the draft guidance document.
Application.’’ The Agency is taking this placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
action in response to a request for an those submitted as ‘‘Confidential Elizabeth Giaquinto Friedman, Office of
extension to allow interested persons Submissions,’’ publicly viewable at Generic Drugs, Center for Drug
additional time to submit comments. https://www.regulations.gov or at the Evaluation and Research, Food and
DATES: FDA is reopening the comment Dockets Management Staff between 9 Drug Administration, 10903 New
period on the notice of availability a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 75, Rm. 1670,
published October 13, 2017 (82 FR Friday. Silver Spring, MD 20993–0002, 240–
47749). Submit either electronic or • Confidential Submissions—To 402–7930.
written comments on the draft guidance submit a comment with confidential
SUPPLEMENTARY INFORMATION:
by February 12, 2018 to ensure that the information that you do not wish to be
Agency considers your comment on this made publicly available, submit your I. Background
draft guidance before it begins work on comments only as a written/paper In the Federal Register of October 13,
the final version of the guidance. submission. You should submit two 2017, FDA published a notice of
ADDRESSES: You may submit comments copies total. One copy will include the availability with a 60-day comment
on any guidance at any time as follows: information you claim to be confidential period to request comments on the draft
with a heading or cover note that states guidance for industry entitled
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS ‘‘Determining Whether to Submit an
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The ANDA or 505(b)(2) Application.’’
following way: Agency will review this copy, including This draft guidance is being issued
• Federal eRulemaking Portal: the claimed confidential information, in consistent with FDA’s good guidance
https://www.regulations.gov. Follow the its consideration of comments. The practices regulation (21 CFR 10.115).
instructions for submitting comments. second copy, which will have the The draft guidance, when finalized, will
Comments submitted electronically, claimed confidential information represent the current thinking of FDA
including attachments, to https:// redacted/blacked out, will be available on factors for applicants to consider
www.regulations.gov will be posted to for public viewing and posted on when determining which one of the
the docket unchanged. Because your https://www.regulations.gov. Submit abbreviated approval pathways under
comment will be made public, you are both copies to the Dockets Management the Federal Food, Drug, and Cosmetic
solely responsible for ensuring that your Staff. If you do not wish your name and Act is appropriate for the submission of
comment does not include any contact information to be made publicly a marketing application to FDA. It does
confidential information that you or a available, you can provide this not establish any rights for any person
third party may not wish to be posted, information on the cover sheet and not and is not binding on FDA or the public.
such as medical information, your or in the body of your comments and you You can use an alternative approach if
anyone else’s Social Security number, or must identify this information as it satisfies the requirements of the
confidential business information, such ‘‘confidential.’’ Any information marked applicable statutes and regulations. This
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed guidance is not subject to Executive
except in accordance with 21 CFR 10.20
sradovich on DSK3GMQ082PROD with NOTICES
that if you include your name, contact Order 12866.
information, or other information that and other applicable disclosure law. For The Agency has received a request for
identifies you in the body of your more information about FDA’s posting a 30-day extension of the comment
comments, that information will be of comments to public dockets, see 80 period for the draft guidance. The
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access request conveyed concern that the
• If you want to submit a comment the information at: https://www.gpo.gov/ requestor did not have sufficient time to
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- develop a meaningful or thoughtful
do not wish to be made available to the 23389.pdf. response to the draft guidance.
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![Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1619
FDA has considered the request and draft guidance before it begins work on comments only as a written/paper
is reopening the comment period for the the final version of the guidance. submission. You should submit two
draft guidance for 30 days, until ADDRESSES: You may submit comments copies total. One copy will include the
February 12, 2018. The Agency believes on any guidance at any time as follows: information you claim to be confidential
that a 30-day reopening of the comment with a heading or cover note that states
period allows adequate time for Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
interested persons to submit comments Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
to ensure that the Agency can consider following way: Agency will review this copy, including
the comments on this draft guidance • Federal eRulemaking Portal: the claimed confidential information, in
before it begins work on the final https://www.regulations.gov. Follow the its consideration of comments. The
version of the guidance. instructions for submitting comments. second copy, which will have the
Comments submitted electronically, claimed confidential information
II. Electronic Access including attachments, to https:// redacted/blacked out, will be available
Persons with access to the internet www.regulations.gov will be posted to for public viewing and posted on
may obtain the draft guidance at either the docket unchanged. Because your https://www.regulations.gov. Submit
https://www.fda.gov/Drugs/Guidance comment will be made public, you are both copies to the Dockets Management
ComplianceRegulatoryInformation/ solely responsible for ensuring that your Staff. If you do not wish your name and
Guidances/default.htm or https:// comment does not include any contact information to be made publicly
www.regulations.gov. confidential information that you or a available, you can provide this
Dated: January 8, 2018.
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
Leslie Kux,
anyone else’s Social Security number, or must identify this information as
Associate Commissioner for Policy. confidential business information, such ‘‘confidential.’’ Any information marked
[FR Doc. 2018–00405 Filed 1–11–18; 8:45 am] as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
BILLING CODE 4164–01–P that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
DEPARTMENT OF HEALTH AND comments, that information will be
HUMAN SERVICES of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
• If you want to submit a comment the information at: https://www.gpo.gov/
Food and Drug Administration
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
[Docket No. FDA–2017–D–6380] public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
Clarification of Orphan Designation of manner detailed (see ‘‘Written/Paper
Drugs and Biologics for Pediatric electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
Subpopulations of Common Diseases;
Draft Guidance for Industry; Written/Paper Submissions www.regulations.gov and insert the
Availability; Extension of Comment docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
Period follows: ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
and/or go to the Dockets Management
HHS. written/paper submissions): Dockets
Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
ACTION:Notice of availability; extension Rockville, MD 20852.
Drug Administration, 5630 Fishers
of comment period. Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:
• For written/paper comments Aaron Friedman, Office of Orphan
SUMMARY: The Food and Drug Products Development, Food and Drug
Administration (FDA or Agency) is submitted to the Dockets Management
Staff, FDA will post your comment, as Administration, 10903 New Hampshire
extending the comment period for the Ave., Bldg. 32, Rm. 5295, Silver Spring,
notice of availability that appeared in well as any attachments, except for
information submitted, marked and MD 20993, 301–796–8660.
the Federal Register of December 20,
identified, as confidential, if submitted SUPPLEMENTARY INFORMATION: In the
2017. In the notice of availability, FDA
as detailed in ‘‘Instructions.’’ Federal Register of December 20, 2017,
requested comments on the draft
Instructions: All submissions received FDA published a notice of availability
guidance for industry entitled
must include the Docket No. FDA– with a 30-day comment period to
‘‘Clarification of Orphan Designation of
2017–D–6380 for ‘‘Clarification of request comments on the draft guidance
Drugs and Biologics for Pediatric
Orphan Designation of Drugs and for industry entitled ‘‘Clarification of
Subpopulations of Common Diseases.’’
Biologics for Pediatric Subpopulations Orphan Designation of Drugs and
The Agency is taking this action in
of Common Diseases.’’ Received Biologics for Pediatric Subpopulations
response to public interest in the draft
comments will be placed in the docket of Common Diseases.’’
guidance and to allow interested This draft guidance is being issued
and, except for those submitted as
persons additional time to submit consistent with FDA’s good guidance
‘‘Confidential Submissions,’’ publicly
comments. practices regulation (21 CFR 10.115).
sradovich on DSK3GMQ082PROD with NOTICES
viewable at https://www.regulations.gov
DATES: FDA is extending the comment or at the Dockets Management Staff The draft guidance, when finalized, will
period on the notice of availability between 9 a.m. and 4 p.m., Monday represent the current thinking of FDA
published December 20, 2017 (82 FR through Friday. on orphan designation of drugs and
60402). Submit either electronic or • Confidential Submissions—To biologics for pediatric subpopulations of
written comments on the draft guidance submit a comment with confidential common diseases. It does not establish
by February 18, 2018, to ensure that the information that you do not wish to be any rights for any person and is not
Agency considers your comment on this made publicly available, submit your binding on FDA or the public. You can
VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1](https://thefederalregister.org/doc/83_FR_1627/page/2.svg)
Document Created: 2018-10-26 09:51:43
Document Modified: 2018-10-26 09:51:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability; reopening of the comment period. | |
| Dates | FDA is reopening the comment period on the notice of availability published October 13, 2017 (82 FR 47749). Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Elizabeth Giaquinto Friedman, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-402-7930. | |
| FR Citation | 83 FR 1618 |
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