82 FR 34679 - Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 142 (July 26, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 142 (July 26, 2017)
| Page Range | 34679-34680 | |
| FR Document | 2017-15654 |
[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)] [Notices] [Pages 34679-34680] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15654] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0880] Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; 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 the guidance entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' The Generic Drug User Fee Amendments of 2012 (GDUFA) are designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for abbreviated new drug applications (ANDAs). This guidance is intended to provide answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. This guidance finalizes the draft guidance originally issued in August 2012 and issued in revised draft form in September 2013. DATES: Submit either electronic or written comments on this guidance at any time. 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): 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-2012-D-0880 for ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' 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. Submit written requests for single copies of this 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 guidance document. FOR FURTHER INFORMATION CONTACT: Sonia Kim, Center for Drug Evaluation and Research, Food and Drug [[Page 34680]] Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, 240-402-5118. SUPPLEMENTARY INFORMATION: I. Background GDUFA (Pub. L. 112-144, Title III) was signed into law by the President on July 9, 2012. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and to improve the review process for ANDAs. GDUFA enables FDA to assess user fees to support critical and measurable enhancements to FDA's generic drugs program. On August 27, 2012, FDA announced the availability of a draft guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers'' (77 FR 51814). On September 10, 2013, FDA announced the availability of a revised version of this guidance (78 FR 55261). The comment period on the revised draft guidance ended on December 11, 2013 (78 FR 70953). FDA received several comments on the draft guidance, and these comments as well as FDA's experience implementing GDUFA were considered as the guidance was finalized. This guidance is intended to provide answers to common questions from generic drug industry participants and other interested parties involved in the development and/or testing of generic drug products regarding FDA's implementation of GDUFA. This guidance includes three categories of questions and answers: Self-identification of facilities, sites, and organizations; review of generic drug submissions; and inspections and compliance. The draft versions of this guidance also addressed the subject of fees. The portion of the draft guidance relating to fees was updated and finalized in November 2016 (81 FR 81774, November 18, 2016). This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self- Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.'' 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. II. Electronic Access Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: July 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15654 Filed 7-25-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices 34679
completing special studies, such as testing of generic drug products and, except for those submitted as
Medicaid spending for special regarding the requirements and ‘‘Confidential Submissions,’’ publicly
education; collaborating with the commitments of GDUFA. This guidance viewable at https://www.regulations.gov
University of Massachusetts and the finalizes the draft guidance originally or at the Dockets Management Staff
University of Minnesota to show issued in August 2012 and issued in between 9 a.m. and 4 p.m., Monday
targeted current year and longitudinal revised draft form in September 2013. through Friday.
data on the project Web site and DATES: Submit either electronic or • Confidential Submissions—To
providing a create-a-chart option written comments on this guidance at submit a comment with confidential
allowing reports to be customized. The any time. information that you do not wish to be
comparative nationwide longitudinal made publicly available, submit your
ADDRESSES: You may submit comments
study of public financial commitments comments only as a written/paper
as follows:
and programmatic trends in submission. You should submit two
developmental disabilities services and Electronic Submissions copies total. One copy will include the
supports is a thirty-year body of work. Submit electronic comments in the information you claim to be confidential
Agency Contact: For further with a heading or cover note that states
following way:
information or comments regarding this ‘‘THIS DOCUMENT CONTAINS
• Federal eRulemaking Portal:
supplemental action, contact Katherine- CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the
Cargill-Willis, U.S. Department of Agency will review this copy, including
Health and Human Services, instructions for submitting comments.
Comments submitted electronically, the claimed confidential information, in
Administration for Community Living, its consideration of comments. The
Administration on Intellectual and including attachments, to https://
www.regulations.gov will be posted to second copy, which will have the
Developmental Disabilities, 330 C Street claimed confidential information
SW., Washington, DC 20201; telephone the docket unchanged. Because your
comment will be made public, you are redacted/blacked out, will be available
202–795–7322; email katherine.cargill- for public viewing and posted on
willis@acl.hhs.gov. solely responsible for ensuring that your
comment does not include any https://www.regulations.gov. Submit
Dated: July 17, 2017. confidential information that you or a both copies to the Dockets Management
Mary Lazare, third party may not wish to be posted, Staff. If you do not wish your name and
Acting Administrator and Assistant Secretary such as medical information, your or contact information to be made publicly
for Aging. anyone else’s Social Security number, or available, you can provide this
[FR Doc. 2017–15662 Filed 7–25–17; 8:45 am] confidential business information, such information on the cover sheet and not
BILLING CODE 4154–01–P as a manufacturing process. Please note in the body of your comments and you
that if you include your name, contact must identify this information as
information, or other information that ‘‘confidential.’’ Any information marked
DEPARTMENT OF HEALTH AND identifies you in the body of your as ‘‘confidential’’ will not be disclosed
HUMAN SERVICES comments, that information will be except in accordance with 21 CFR 10.20
posted on https://www.regulations.gov. and other applicable disclosure law. For
Food and Drug Administration more information about FDA’s posting
• If you want to submit a comment
[Docket No. FDA–2012–D–0880] with confidential information that you of comments to public dockets, see 80
do not wish to be made available to the FR 56469, September 18, 2015, or access
Generic Drug User Fee Amendments of public, submit the comment as a the information at: https://www.gpo.gov/
2012: Questions and Answers Related written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
to Self-Identification of Facilities, manner detailed (see ‘‘Written/Paper 23389.pdf.
Review of Generic Drug Submissions, Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
and Inspections and Compliance; read background documents or the
Guidance for Industry; Availability Written/Paper Submissions electronic and written/paper comments
Submit written/paper submissions as received, go to https://
AGENCY: Food and Drug Administration,
follows: www.regulations.gov and insert the
HHS.
ACTION: Notice of availability. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
written/paper submissions): Dockets heading of this document, into the
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Administration (FDA or Agency) is Drug Administration, 5630 Fishers and/or go to the Dockets Management
announcing the availability of the Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
guidance entitled ‘‘Generic Drug User • For written/paper comments Rockville, MD 20852.
Fee Amendments of 2012: Questions submitted to the Dockets Management Submit written requests for single
and Answers Related to Self- Staff, FDA will post your comment, as copies of this guidance to the Division
Identification of Facilities, Review of well as any attachments, except for of Drug Information, Center for Drug
Generic Drug Submissions, and information submitted, marked and Evaluation and Research, Food and
Inspections and Compliance.’’ The identified, as confidential, if submitted Drug Administration, 10001 New
Generic Drug User Fee Amendments of as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
2012 (GDUFA) are designed to speed the Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
delivery of safe and effective generic must include the Docket No. FDA– 0002. Send one self-addressed adhesive
mstockstill on DSK30JT082PROD with NOTICES
drugs to the public and to improve the 2012–D–0880 for ‘‘Generic Drug User label to assist that office in processing
review process for abbreviated new drug Fee Amendments of 2012: Questions your requests. See the SUPPLEMENTARY
applications (ANDAs). This guidance is and Answers Related to Self- INFORMATION section for electronic
intended to provide answers to common Identification of Facilities, Review of access to the guidance document.
questions from the generic drug Generic Drug Submissions, and FOR FURTHER INFORMATION CONTACT:
industry and other interested parties Inspections and Compliance.’’ Received Sonia Kim, Center for Drug Evaluation
involved in the development and/or comments will be placed in the docket and Research, Food and Drug
VerDate Sep<11>2014 17:49 Jul 25, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1](https://thefederalregister.org/doc/82_FR_34821/page/1.svg)
![34680 Federal Register / Vol. 82, No. 142 / Wednesday, July 26, 2017 / Notices
Administration, 10001 New Hampshire II. Electronic Access the docket unchanged. Because your
Ave., Hillandale Building, 4th Floor, Persons with access to the Internet comment will be made public, you are
Silver Spring, MD 20993–0002, 240– may obtain the guidance at either solely responsible for ensuring that your
402–5118. https://www.fda.gov/Drugs/Guidance comment does not include any
SUPPLEMENTARY INFORMATION: ComplianceRegulatoryInformation/ confidential information that you or a
Guidances/default.htm or https:// third party may not wish to be posted,
I. Background such as medical information, your or
www.regulations.gov.
GDUFA (Pub. L. 112–144, Title III) anyone else’s Social Security number, or
Dated: July 20, 2017. confidential business information, such
was signed into law by the President on
Anna K. Abram, as a manufacturing process. Please note
July 9, 2012. GDUFA is designed to
speed the delivery of safe and effective Deputy Commissioner for Policy, Planning, that if you include your name, contact
Legislation, and Analysis. information, or other information that
generic drugs to the public and to
improve the review process for ANDAs. [FR Doc. 2017–15654 Filed 7–25–17; 8:45 am] identifies you in the body of your
GDUFA enables FDA to assess user fees BILLING CODE 4164–01–P comments, that information will be
to support critical and measurable posted on https://www.regulations.gov.
enhancements to FDA’s generic drugs • If you want to submit a comment
program. DEPARTMENT OF HEALTH AND with confidential information that you
On August 27, 2012, FDA announced HUMAN SERVICES do not wish to be made available to the
the availability of a draft guidance for public, submit the comment as a
Food and Drug Administration written/paper submission and in the
industry entitled ‘‘Generic Drug User
Fee Amendments of 2012: Questions [Docket No. FDA–2017–D–3906] manner detailed (see ‘‘Written/Paper
and Answers’’ (77 FR 51814). On Submissions’’ and ‘‘Instructions’’).
September 10, 2013, FDA announced Consumer Antiseptic Wash Final Rule Written/Paper Submissions
the availability of a revised version of Questions and Answers; Guidance for
Industry; Small Entity Compliance Submit written/paper submissions as
this guidance (78 FR 55261). The follows:
comment period on the revised draft Guide; Availability
• Mail/Hand delivery/Courier (for
guidance ended on December 11, 2013 AGENCY: Food and Drug Administration, written/paper submissions): Dockets
(78 FR 70953). FDA received several HHS. Management Staff (HFA–305), Food and
comments on the draft guidance, and ACTION: Notice of availability. Drug Administration, 5630 Fishers
these comments as well as FDA’s Lane, Rm. 1061, Rockville, MD 20852.
experience implementing GDUFA were SUMMARY: The Food and Drug • For written/paper comments
considered as the guidance was Administration (FDA, the Agency, or submitted to the Dockets Management
finalized. we) is announcing the availability of a Staff, FDA will post your comment, as
This guidance is intended to provide guidance for industry entitled well as any attachments, except for
answers to common questions from ‘‘Consumer Antiseptic Wash Final Rule information submitted, marked, and
generic drug industry participants and Questions and Answers.’’ We are identified as confidential, if submitted
other interested parties involved in the issuing this guidance in accordance as detailed in ‘‘Instructions.’’
development and/or testing of generic with the Small Business Regulatory Instructions: All submissions received
drug products regarding FDA’s Enforcement Fairness Act to assist small must include the Docket No. FDA–
implementation of GDUFA. This businesses in better understanding and 2017–D–3906 for ‘‘Consumer Antiseptic
guidance includes three categories of complying with the consumer antiseptic Wash Final Rule Questions and
questions and answers: Self- wash final rule, which established that Answers; Guidance for Industry; Small
identification of facilities, sites, and certain active ingredients, including Entity Compliance Guide.’’ Received
organizations; review of generic drug triclosan, used in over-the-counter comments will be placed in the docket
submissions; and inspections and (OTC) consumer antiseptic wash and, except for those submitted as
compliance. The draft versions of this products are not generally recognized as ‘‘Confidential Submissions,’’ publicly
guidance also addressed the subject of safe and effective (GRASE). This viewable at https://www.regulations.gov
fees. The portion of the draft guidance guidance explains the scope of the final or at the Dockets Management Staff
relating to fees was updated and rule, how and when manufacturers must between 9 a.m. and 4 p.m., Monday
finalized in November 2016 (81 FR comply with the final rule, and which through Friday.
81774, November 18, 2016). consumer antiseptic wash active • Confidential Submissions—To
This guidance is being issued ingredients were deferred from the final submit a comment with confidential
consistent with FDA’s good guidance rule. information that you do not wish to be
practices regulation (21 CFR 10.115). DATES: Submit either electronic or made publicly available, submit your
The guidance represents the current written comments on Agency guidances comments only as a written/paper
thinking of FDA on ‘‘Generic Drug User at any time. submission. You should submit two
Fee Amendments of 2012: Questions ADDRESSES: You may submit comments copies total. One copy will include the
and Answers Related to Self- as follows: information you claim to be confidential
Identification of Facilities, Review of with a heading or cover note that states
Generic Drug Submissions, and Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
Inspections and Compliance.’’ It does Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
mstockstill on DSK30JT082PROD with NOTICES
not establish any rights for any person following way: Agency will review this copy, including
and is not binding on FDA or the public. • Federal eRulemaking Portal: the claimed confidential information, in
You can use an alternative approach if https://www.regulations.gov. Follow the its consideration of comments. The
it satisfies the requirements of the instructions for submitting comments. second copy, which will have the
applicable statutes and regulations. This Comments submitted electronically, claimed confidential information
guidance is not subject to Executive including attachments, to https:// redacted/blacked out, will be available
Order 12866. www.regulations.gov will be posted to for public viewing and posted on
VerDate Sep<11>2014 17:49 Jul 25, 2017 Jkt 241001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\26JYN1.SGM 26JYN1](https://thefederalregister.org/doc/82_FR_34821/page/2.svg)
Document Created: 2017-07-26 01:30:01
Document Modified: 2017-07-26 01:30:01
| 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. | |
| Dates | Submit either electronic or written comments on this guidance at any time. | |
| Contact | Sonia Kim, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, 240-402-5118. | |
| FR Citation | 82 FR 34679 |
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