82_FR_4370 82 FR 4361 - 180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; Availability

82 FR 4361 - 180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 9 (January 13, 2017)

Page Range4361-4362
FR Document2017-00631

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``180-Day Exclusivity: Questions and Answers.'' This draft guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly is known as ``180-day exclusivity'' for generic drug products. As a general matter, FDA has implemented these statutory provisions within the context of application-specific decisions. Some FDA decisions have been made publicly available (e.g., in FDA citizen petition responses and documents released in litigation). FDA believes that a guidance for industry that provides answers to commonly asked questions about 180-day exclusivity would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products. FDA intends to update this guidance to include additional questions and answers as appropriate.

Federal Register, Volume 82 Issue 9 (Friday, January 13, 2017) 
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4361-4362]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-00631]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4645]


180-Day Exclusivity: Questions and Answers; Draft Guidance for 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the availability of a draft guidance for industry entitled ``180-Day 
Exclusivity: Questions and Answers.'' This draft guidance is intended 
to address questions that have been raised about the provisions of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic 
drug exclusivity, which commonly is known as ``180-day exclusivity'' 
for generic drug products. As a general matter, FDA has implemented 
these statutory provisions within the context of application-specific 
decisions. Some FDA decisions have been made publicly available (e.g., 
in FDA citizen petition responses and documents released in 
litigation). FDA believes that a guidance for industry that provides 
answers to commonly asked questions about 180-day exclusivity would 
enhance transparency and facilitate the development, approval, and 
timely marketing of generic drug products. FDA intends to update this 
guidance to include additional questions and answers as appropriate.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 14, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-4645 for ``180-Day Exclusivity: Questions and Answers.'' 
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 Division of Dockets Management 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

[[Page 4362]]

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 Division of 
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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; or to the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Harry Schwirck, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 301-
796-4271; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``180-Day Exclusivity: Questions and Answers.'' This draft 
guidance is intended to address questions that have been raised about 
the provisions of the FD&C Act, which relate to 180-day exclusivity for 
generic drug products. These provisions provide an incentive and reward 
to generic drug applicants that expose themselves to the risk of patent 
litigation that may arise during the abbreviated new drug application 
(ANDA) process (see section 505(j) of the FD&C Act (21 U.S.C. 355(j)). 
It does so by providing for a 180-day period of marketing exclusivity 
vis-a-vis certain other ANDA applicants to the first applicant(s) who 
are eligible for the exclusivity under applicable statutory provisions 
(see section 505(j)(2) and (j)(5) of the FD&C Act).
    FDA has received a number of questions about 180-day exclusivity 
and has identified commonly asked questions for inclusion in the 
guidance. FDA expects the information provided in the guidance to 
enhance transparency and facilitate the development, approval, and 
timely marketing of generic drug products. FDA intends to update the 
guidance to include additional questions and answers as appropriate.
    The draft guidance contains questions and answers organized 
according to subject matter. The subject areas are: Applicable 
statutory scheme, first applicants, 180-day exclusivity and patents, 
180-day exclusivity trigger and scope, 180-day exclusivity 
relinquishment and waiver, forfeiture of 180-day exclusivity, and 
procedural questions regarding 180-day exclusivity determinations.
    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 ``180-Day 
Exclusivity: Questions and Answers.'' 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.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00631 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4361 TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Total Number of Average burden per Type of recordkeeping records per annual Total hours recordkeepers recordkeeping recordkeeper records Records that the outsourcing facility maintains of 5 30 150 0.083 (5 minutes) ...... 12.5 the testing performed in accordance with Ap- pendix A of the guidance. 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The draft guidance also references SUMMARY: The Food and Drug anyone else’s Social Security number, or registration, adverse event reporting, Administration (FDA or Agency) is confidential business information, such product reporting, and current good announcing the availability of a draft as a manufacturing process. Please note manufacturing practice (CGMP) guidance for industry entitled ‘‘180-Day that if you include your name, contact requirements for outsourcing facilities. Exclusivity: Questions and Answers.’’ information, or other information that The collections of information for This draft guidance is intended to identifies you in the body of your outsourcing facility registration have address questions that have been raised comments, that information will be been approved by the Office of about the provisions of the Federal posted on https://www.regulations.gov. Management and Budget (OMB) under Food, Drug, and Cosmetic Act (FD&C • If you want to submit a comment OMB control number 0910–0777 (79 FR Act) that relate to generic drug with confidential information that you 69859). The collections of information exclusivity, which commonly is known do not wish to be made available to the for adverse event reporting by as ‘‘180-day exclusivity’’ for generic public, submit the comment as a outsourcing facilities have been drug products. As a general matter, FDA written/paper submission and in the approved by OMB under OMB control has implemented these statutory manner detailed (see ‘‘Written/Paper number 0910–0800 (80 FR 60917). In provisions within the context of Submissions’’ and ‘‘Instructions’’). the Federal Register of December 4, application-specific decisions. Some FDA decisions have been made publicly Written/Paper Submissions 2013 (78 FR 72897), FDA estimated the burden resulting from outsourcing available (e.g., in FDA citizen petition Submit written/paper submissions as facility electronic drug product responses and documents released in follows: reporting. In the Federal Register of July litigation). FDA believes that a guidance • Mail/Hand delivery/Courier (for 2, 2014 (79 FR 37743), FDA estimated for industry that provides answers to written/paper submissions): Division of the burden resulting from outsourcing commonly asked questions about 180- Dockets Management (HFA–305), Food facility compliance with CGMP day exclusivity would enhance and Drug Administration, 5630 Fishers requirements. transparency and facilitate the Lane, Rm. 1061, Rockville, MD 20852. development, approval, and timely • For written/paper comments IV. Electronic Access marketing of generic drug products. submitted to the Division of Dockets Persons with access to the Internet FDA intends to update this guidance to Management, FDA will post your can obtain the document at either http:// include additional questions and comment, as well as any attachments, www.fda.gov/Drugs/ answers as appropriate. except for information submitted, GuidanceComplianceRegulatory DATES: Although you can comment on marked and identified, as confidential, Information/Guidances/default.htm, any guidance at any time (see 21 CFR if submitted as detailed in http://www.fda.gov/BiologicsBlood 10.115(g)(5)), to ensure that the Agency ‘‘Instructions.’’ Vaccines/GuidanceCompliance considers your comment on this draft Instructions: All submissions received RegulatoryInformation/default.htm or guidance before it begins work on the must include the Docket No. FDA– https://www.regulations.gov. final version of the guidance, submit 2016–D–4645 for ‘‘180-Day Exclusivity: either electronic or written comments Questions and Answers.’’ Received Dated: January 10, 2016. on the draft guidance by March 14, comments will be placed in the docket Leslie Kux, 2017. and, except for those submitted as Associate Commissioner for Policy. ‘‘Confidential Submissions,’’ publicly ADDRESSES: You may submit comments [FR Doc. 2017–00722 Filed 1–12–17; 8:45 am] viewable at https://www.regulations.gov as follows: BILLING CODE 4164–01–P or at the Division of Dockets Electronic Submissions Management between 9 a.m. and 4 p.m., Submit electronic comments in the Monday through Friday. DEPARTMENT OF HEALTH AND following way: • Confidential Submissions—To HUMAN SERVICES • Federal eRulemaking Portal: submit a comment with confidential https://www.regulations.gov. Follow the information that you do not wish to be Food and Drug Administration instructions for submitting comments. made publicly available, submit your Comments submitted electronically, comments only as a written/paper [Docket No. FDA–2016–D–4645] including attachments, to https:// submission. You should submit two asabaliauskas on DSK3SPTVN1PROD with NOTICES www.regulations.gov will be posted to copies total. One copy will include the 180-Day Exclusivity: Questions and the docket unchanged. Because your information you claim to be confidential Answers; Draft Guidance for Industry; comment will be made public, you are with a heading or cover note that states Availability solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS AGENCY: Food and Drug Administration, comment does not include any CONFIDENTIAL INFORMATION.’’ The HHS. confidential information that you or a Agency will review this copy, including third party may not wish to be posted, the claimed confidential information, in ACTION: Notice of availability. such as medical information, your or its consideration of comments. The VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1

4362 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices second copy, which will have the I. Background Information/Guidances/default.htm, or claimed confidential information https://www.regulations.gov. redacted/blacked out, will be available FDA is announcing the availability of a draft guidance for industry entitled Dated: January 9, 2017. for public viewing and posted on Leslie Kux, ‘‘180-Day Exclusivity: Questions and https://www.regulations.gov. Submit Answers.’’ This draft guidance is Associate Commissioner for Policy. both copies to the Division of Dockets intended to address questions that have [FR Doc. 2017–00631 Filed 1–12–17; 8:45 am] Management. If you do not wish your been raised about the provisions of the BILLING CODE 4164–01–P name and contact information to be FD&C Act, which relate to 180-day made publicly available, you can exclusivity for generic drug products. provide this information on the cover DEPARTMENT OF HEALTH AND These provisions provide an incentive sheet and not in the body of your HUMAN SERVICES and reward to generic drug applicants comments and you must identify this that expose themselves to the risk of information as ‘‘confidential.’’ Any Food and Drug Administration patent litigation that may arise during information marked as ‘‘confidential’’ the abbreviated new drug application [Docket No. FDA–2016–D–1025] will not be disclosed except in (ANDA) process (see section 505(j) of accordance with 21 CFR 10.20 and other the FD&C Act (21 U.S.C. 355(j)). It does Emergency Use Authorization of applicable disclosure law. For more so by providing for a 180-day period of Medical Products and Related information about FDA’s posting of marketing exclusivity vis-a-vis certain Authorities; Guidance for Industry and comments to public dockets, see 80 FR other ANDA applicants to the first Other Stakeholders; Availability 56469, September 18, 2015, or access applicant(s) who are eligible for the the information at: http://www.fda.gov/ exclusivity under applicable statutory AGENCY: Food and Drug Administration, regulatoryinformation/dockets/ provisions (see section 505(j)(2) and HHS. default.htm. (j)(5) of the FD&C Act). ACTION: Notice of availability. Docket: For access to the docket to FDA has received a number of SUMMARY: The Food and Drug read background documents or the questions about 180-day exclusivity and Administration (FDA or Agency) is electronic and written/paper comments has identified commonly asked announcing the availability of a received, go to https:// questions for inclusion in the guidance. guidance for industry and other www.regulations.gov and insert the FDA expects the information provided stakeholders entitled ‘‘Emergency Use docket number, found in brackets in the in the guidance to enhance transparency Authorization of Medical Products and heading of this document, into the and facilitate the development, Related Authorities.’’ The purpose of ‘‘Search’’ box and follow the prompts approval, and timely marketing of this guidance is to explain FDA’s and/or go to the Division of Dockets generic drug products. FDA intends to current thinking on the authorization of Management, 5630 Fishers Lane, Rm. update the guidance to include the emergency use of certain medical 1061, Rockville, MD 20852. additional questions and answers as products under certain sections of the Submit written requests for single appropriate. Federal Food, Drug, and Cosmetic Act copies of the draft guidance to the The draft guidance contains questions (the FD&C Act) as amended or added by Division of Drug Information, Center for and answers organized according to the Pandemic and All-Hazards Drug Evaluation and Research, Food subject matter. The subject areas are: Preparedness Reauthorization Act of and Drug Administration, 10001 New Applicable statutory scheme, first 2013 (PAHPRA). The provisions in Hampshire Ave., Hillandale Building, applicants, 180-day exclusivity and PAHPRA include key legal authorities 4th Floor, Silver Spring, MD 20993– patents, 180-day exclusivity trigger and to sustain and strengthen national 0002; or to the Office of scope, 180-day exclusivity preparedness for public health, military, Communication, Outreach, and relinquishment and waiver, forfeiture of and domestic emergencies involving Development, Center for Biologics 180-day exclusivity, and procedural chemical, biological, radiological, and Evaluation and Research, Food and questions regarding 180-day exclusivity nuclear (CBRN) agents, including Drug Administration, 10903 New determinations. emerging infectious disease threats. Hampshire Ave., Bldg. 71, Rm. 3128, This draft guidance is being issued DATES: Submit either electronic or Silver Spring, MD 20993–0002. Send consistent with FDA’s good guidance written comments on Agency guidances one self-addressed adhesive label to practices regulation (21 CFR 10.115). at any time. assist that office in processing your The draft guidance, when finalized, will ADDRESSES: You may submit comments requests. See the SUPPLEMENTARY represent the current thinking of FDA as follows: INFORMATION section for electronic on ‘‘180-Day Exclusivity: Questions and access to the draft guidance document. Answers.’’ It does not establish any Electronic Submissions rights for any person and is not binding Submit electronic comments in the FOR FURTHER INFORMATION CONTACT: on FDA or the public. You can use an following way: Harry Schwirck, Center for Drug alternative approach if it satisfies the • Federal eRulemaking Portal: http:// Evaluation and Research, Food and requirements of the applicable statutes www.regulations.gov. Follow the Drug Administration, 10903 New and regulations. instructions for submitting comments. Hampshire Ave., Bldg. 75, Rm. 1672, Comments submitted electronically, asabaliauskas on DSK3SPTVN1PROD with NOTICES Silver Spring, MD 20993–0002, 301– II. Electronic Access including attachments, to http:// 796–4271; or Stephen Ripley, Center for Persons with access to the Internet www.regulations.gov will be posted to Biologics Evaluation and Research, may obtain the draft guidance at either the docket unchanged. Because your Food and Drug Administration, 10903 http://www.fda.gov/Drugs/Guidance comment will be made public, you are New Hampshire Ave., Bldg. 71, Rm. ComplianceRegulatoryInformation/ solely responsible for ensuring that your 7301, Silver Spring, MD 20993–0002, Guidances/default.htm, http:// comment does not include any 240–402–7911. www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a SUPPLEMENTARY INFORMATION: GuidanceComplianceRegulatory third party may not wish to be posted, VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\13JAN1.SGM 13JAN1


Document Created: 2017-01-13 02:45:17
Document Modified: 2017-01-13 02:45:17
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.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 14, 2017.
ContactHarry Schwirck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 301- 796-4271; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation82 FR 4361 
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