83_FR_535 83 FR 532 - Good Abbreviated New Drug Application Submission Practices; Draft Guidance for Industry; Availability

83 FR 532 - Good Abbreviated New Drug Application Submission Practices; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 3 (January 4, 2018)

Page Range532-533
FR Document2017-28435

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Good ANDA Submission Practices.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This draft guidance highlights common, recurring deficiencies that may lead to a delay in the approval of an ANDA. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for approval.

Federal Register, Volume 83 Issue 3 (Thursday, January 4, 2018) 
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Notices]
[Pages 532-533]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6854]


Good Abbreviated New Drug Application Submission Practices; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Good ANDA 
Submission Practices.'' This guidance is intended to assist applicants 
preparing to submit to FDA abbreviated new drug applications (ANDAs). 
This draft guidance highlights common, recurring deficiencies that may 
lead to a delay in the approval of an ANDA. It also makes 
recommendations to applicants on how to avoid these deficiencies with 
the goal of minimizing the number of review cycles necessary for 
approval.

DATES: Submit either electronic or written comments on the draft 
guidance by March 5, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-6854 for ``Good ANDA Submission Practices.'' 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

[[Page 533]]

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: Michelle Sollenberger, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240-
402-0981.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Good ANDA Submission Practices.'' This draft guidance is 
intended to assist applicants preparing to submit ANDAs to FDA. It 
highlights common, recurring deficiencies that may lead to a delay in 
the approval of an ANDA. This draft guidance also makes recommendations 
to applicants on how to avoid these deficiencies so that applicants can 
submit ANDAs that may be approved in the first review cycle. This draft 
guidance has been developed as part of FDA's ``Drug Competition Action 
Plan,'' which, in coordination with the Generic Drug User Fee 
Amendments (GDUFA I and II) (Pub. L. 112-144 and Pub. L. 115-52, 
respectively) and other FDA activities, is expected to increase 
competition in the market for prescription drugs, facilitate entry of 
high-quality and affordable generic drugs, and improve public health.
    In conjunction with this draft guidance, FDA is issuing a Good ANDA 
Assessment Practices Manual of Policies and Procedures, which 
establishes good ANDA assessment practices for the Office of Generic 
Drugs and the Office of Pharmaceutical Quality to increase their 
operational efficiency and effectiveness. This draft guidance and the 
Manual of Policies and Procedures are intended to build upon the 
success of the GDUFA program and to help reduce the number of review 
cycles for an ANDA to attain approval.
    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 good ANDA 
submission practices. 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. 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 collections of information in the draft guidance have been 
approved under OMB control numbers 0910-0001 and 0910-0786.

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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28435 Filed 1-3-18; 8:45 am]
 BILLING CODE 4164-01-P

532 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices agencies to provide services in Respondents: All state and tribal CSE intergovernmental cases. agencies. ANNUAL BURDEN ESTIMATES Average Number of Number of burden hours Total Instrument responses per respondents per burden hours respondent response Intergovernmental Reference Guide: State Profile Guidance—(States and Territories) .................................................................................................... 54 18 0.3 291.6 Intergovernmental Reference Guide: Tribal Profile Guidance ........................ 62 18 0.3 334.8 Total .......................................................................................................... ........................ ........................ ........................ 626.4 Estimated Total Annual Burden DEPARTMENT OF HEALTH AND confidential information that you or a Hours: 626.4 hours. HUMAN SERVICES third party may not wish to be posted, In compliance with the requirements such as medical information, your or Food and Drug Administration anyone else’s Social Security number, or of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the [Docket No. FDA–2017–D–6854] confidential business information, such as a manufacturing process. Please note Administration for Children and Good Abbreviated New Drug that if you include your name, contact Families is soliciting public comment Application Submission Practices; information, or other information that on the specific aspects of the identifies you in the body of your Draft Guidance for Industry; information collection described above. comments, that information will be Availability Copies of the proposed collection of posted on https://www.regulations.gov. information can be obtained and AGENCY: Food and Drug Administration, • If you want to submit a comment comments may be forwarded by writing HHS. with confidential information that you to the Administration for Children and ACTION: Notice of availability. do not wish to be made available to the Families, Office of Administration, public, submit the comment as a SUMMARY: The Food and Drug Office of Planning, Research and written/paper submission and in the Administration (FDA or Agency) is Evaluation, 330 C Street SW, manner detailed (see ‘‘Written/Paper announcing the availability of a draft Washington, DC 20201, Attn: ACF Submissions’’ and ‘‘Instructions’’). guidance for industry entitled ‘‘Good Reports Clearance Officer. Email ANDA Submission Practices.’’ This Written/Paper Submissions address infocollection@acf.hhs.gov. All guidance is intended to assist applicants Submit written/paper submissions as requests should be identified by the title preparing to submit to FDA abbreviated follows: of the information collection. new drug applications (ANDAs). This • Mail/Hand delivery/Courier (for The department specifically requests draft guidance highlights common, written/paper submissions): Dockets comments on: (a) Whether the proposed recurring deficiencies that may lead to Management Staff (HFA–305), Food and collection of information is necessary a delay in the approval of an ANDA. It Drug Administration, 5630 Fishers for the proper performance of the also makes recommendations to Lane, Rm. 1061, Rockville, MD 20852. functions of the agency, including applicants on how to avoid these • For written/paper comments whether the information shall have deficiencies with the goal of minimizing submitted to the Dockets Management the number of review cycles necessary Staff, FDA will post your comment, as practical utility; (b) the accuracy of the for approval. well as any attachments, except for agency’s estimate of the burden of the DATES: Submit either electronic or information submitted, marked and proposed collection of information; (c) the quality, utility, and clarity of the written comments on the draft guidance identified, as confidential, if submitted by March 5, 2018 to ensure that the as detailed in ‘‘Instructions.’’ information to be collected; and, (d) Agency considers your comment on this Instructions: All submissions received ways to minimize the burden of the draft guidance before it begins work on must include the Docket No. FDA– collection of information on the final version of the guidance. 2017–D–6854 for ‘‘Good ANDA respondents, including through the use Submission Practices.’’ Received ADDRESSES: You may submit comments of automated collection techniques or comments will be placed in the docket on any guidance at any time as follows: other forms of information technology. and, except for those submitted as Consideration will be given to Electronic Submissions ‘‘Confidential Submissions,’’ publicly comments and suggestions submitted Submit electronic comments in the viewable at https://www.regulations.gov within 60 days of this publication. following way: or at the Dockets Management Staff Robert Sargis, • Federal eRulemaking Portal: between 9 a.m. and 4 p.m., Monday https://www.regulations.gov. Follow the through Friday. Report Clearance Officer. instructions for submitting comments. • Confidential Submissions—To ethrower on DSK3G9T082PROD with NOTICES [FR Doc. 2017–28443 Filed 1–3–18; 8:45 am] Comments submitted electronically, submit a comment with confidential BILLING CODE 4184–41–P including attachments, to https:// information that you do not wish to be www.regulations.gov will be posted to made publicly available, submit your the docket unchanged. Because your comments only as a written/paper comment will be made public, you are submission. You should submit two solely responsible for ensuring that your copies total. One copy will include the comment does not include any information you claim to be confidential VerDate Sep<11>2014 16:16 Jan 03, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\04JAN1.SGM 04JAN1

Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices 533 with a heading or cover note that states applicants preparing to submit ANDAs Dated: December 26, 2017. ‘‘THIS DOCUMENT CONTAINS to FDA. It highlights common, recurring Leslie Kux, CONFIDENTIAL INFORMATION.’’ The deficiencies that may lead to a delay in Associate Commissioner for Policy. Agency will review this copy, including the approval of an ANDA. This draft [FR Doc. 2017–28435 Filed 1–3–18; 8:45 am] the claimed confidential information, in guidance also makes recommendations BILLING CODE 4164–01–P its consideration of comments. The to applicants on how to avoid these second copy, which will have the deficiencies so that applicants can claimed confidential information submit ANDAs that may be approved in DEPARTMENT OF THE INTERIOR redacted/blacked out, will be available the first review cycle. This draft for public viewing and posted on guidance has been developed as part of Fish and Wildlife Service https://www.regulations.gov. Submit FDA’s ‘‘Drug Competition Action Plan,’’ both copies to the Dockets Management which, in coordination with the Generic [FWS–R1–ES–2017–N161; FXES11140100000–189–FF01E00000] Staff. If you do not wish your name and Drug User Fee Amendments (GDUFA I contact information to be made publicly and II) (Pub. L. 112–144 and Pub. L. Proposed Graysmarsh Safe Harbor available, you can provide this 115–52, respectively) and other FDA Agreement for the Taylor’s information on the cover sheet and not activities, is expected to increase Checkerspot Butterfly, Clallam County, in the body of your comments and you competition in the market for Washington must identify this information as prescription drugs, facilitate entry of ‘‘confidential.’’ Any information marked high-quality and affordable generic AGENCY: Fish and Wildlife Service, as ‘‘confidential’’ will not be disclosed drugs, and improve public health. Interior. except in accordance with 21 CFR 10.20 In conjunction with this draft ACTION: Notice of availability; request and other applicable disclosure law. For guidance, FDA is issuing a Good ANDA for comments. more information about FDA’s posting Assessment Practices Manual of Policies of comments to public dockets, see 80 SUMMARY: Graysmarsh, LLC, hereafter and Procedures, which establishes good FR 56469, September 18, 2015, or access referred to as the applicant, has applied ANDA assessment practices for the the information at: https://www.gpo.gov/ to the U.S. Fish and Wildlife Service Office of Generic Drugs and the Office fdsys/pkg/FR-2015-09-18/pdf/2015- (Service, us) for an enhancement of of Pharmaceutical Quality to increase 23389.pdf. survival permit (permit) pursuant to the their operational efficiency and Docket: For access to the docket to Endangered Species Act of 1973, as effectiveness. This draft guidance and read background documents or the amended. The permit application the Manual of Policies and Procedures electronic and written/paper comments includes a draft safe harbor agreement are intended to build upon the success received, go to https:// (SHA). The permit would authorize of the GDUFA program and to help www.regulations.gov and insert the incidental take of the endangered reduce the number of review cycles for docket number, found in brackets in the Taylor’s checkerspot butterfly. We have an ANDA to attain approval. heading of this document, into the prepared a draft environmental action ‘‘Search’’ box and follow the prompts This draft guidance is being issued statement (EAS) for our preliminary and/or go to the Dockets Management consistent with FDA’s good guidance determination that the SHA and permit Staff, 5630 Fishers Lane, Rm. 1061, practices regulation (21 CFR 10.115). decision may be eligible for categorical Rockville, MD 20852. The draft guidance, when finalized, will exclusion under the National You may submit comments on any represent the current thinking of FDA Environmental Policy Act (NEPA). We guidance at any time (see 21 CFR on good ANDA submission practices. It invite the public to review and 10.115(g)(5)). does not establish any rights for any comment on the permit application, Submit written requests for single person and is not binding on FDA or the draft SHA, and the draft EAS. copies of the draft guidance to the public. You can use an alternative DATES: To ensure consideration, please Division of Drug Information, Center for approach if it satisfies the requirements send your written comments by Drug Evaluation and Research, Food of the applicable statutes and February 5, 2018. and Drug Administration, 10001 New regulations. This draft guidance is not ADDRESSES: You may view or download Hampshire Ave., Hillandale Building, subject to Executive Order 12866. copies of the draft SHA, and draft EAS 4th Floor, Silver Spring, MD 20993– II. Paperwork Reduction Act of 1995 and obtain additional information on 0002. Send one self-addressed adhesive the internet at http://www.fws.gov/ label to assist that office in processing This draft guidance refers to wafwo/ or obtain hard copies or a CD– your requests. See the SUPPLEMENTARY previously approved collections of ROM by calling the phone number INFORMATION section for electronic information that are subject to review by listed below. You may submit access to the draft guidance document. the Office of Management and Budget comments or requests for more FOR FURTHER INFORMATION CONTACT: (OMB) under the Paperwork Reduction information by any of the following Michelle Sollenberger, Center for Drug Act of 1995 (44 U.S.C. 3501–3520). The methods: Evaluation and Research, Food and collections of information in the draft • Email: wfwocomments@fws.gov. Drug Administration, 10903 New guidance have been approved under Include ‘‘Graysmarsh SHA’’ in the Hampshire Ave., Bldg. 75, Rm. 1673, OMB control numbers 0910–0001 and subject line of the message. Silver Spring, MD 20993–0002, 240– 0910–0786. • U.S. Mail: Mark Ostwald, U.S. Fish 402–0981. III. Electronic Access and Wildlife Service, Washington Fish ethrower on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: and Wildlife Office, 510 Desmond Persons with access to the internet Drive, Southeast, Suite 102, Lacey, WA I. Background may obtain the draft guidance at either 98503. FDA is announcing the availability of https://www.fda.gov/Drugs/Guidance • In-Person Drop-off, Viewing, or a draft guidance for industry entitled ComplianceRegulatoryInformation/ Pickup: Call 360–753–9564 to make an ‘‘Good ANDA Submission Practices.’’ Guidances/default.htm or https:// appointment (necessary for viewing/ This draft guidance is intended to assist www.regulations.gov. pickup only) during regular business VerDate Sep<11>2014 16:16 Jan 03, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\04JAN1.SGM 04JAN1


Document Created: 2018-01-04 02:02:00
Document Modified: 2018-01-04 02:02:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by March 5, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactMichelle Sollenberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 240- 402-0981.
FR Citation83 FR 532 
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