82 FR 60018 - Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 241 (December 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 241 (December 18, 2017)
| Page Range | 60018-60019 | |
| FR Document | 2017-27124 |
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)] [Notices] [Pages 60018-60019] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27124] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6752] Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Information Requests and Discipline Review Letters Under GDUFA.'' This draft guidance explains how FDA will issue and use an information request (IR) and/or a discipline review letter (DRL) during the review of an original abbreviated new drug application (ANDA). DATES: Submit either electronic or written comments on the draft guidance by February 16, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-6752 for ``Information Requests and Discipline Review Letters Under GDUFA.'' 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: Philip Bonforte, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993-0002, 240- 402-9871, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Information Requests and Discipline Review Letters Under GDUFA.'' Under the first iteration of the Generic Drug User Fee Amendments of 2012 [[Page 60019]] (GDUFA I), beginning October 1, 2012, FDA agreed to act on received ANDAs within established time frames. As part of this undertaking, the Agency instituted the use of multiple forms of communicating with an applicant regarding the review of an application, including issuance of Complete Response Letters (CRLs) and IRs.\1\ --------------------------------------------------------------------------- \1\ Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), Public Law 112-144 (2012). FDASIA includes GDUFA I, and by reference, the Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA I Commitment Letter). --------------------------------------------------------------------------- Under GDUFA I, FDA issued a CRL after completing a review of an ANDA. The CRL described all the deficiencies identified in the ANDA that must be satisfactorily addressed before the ANDA can be approved. Issuance of a CRL also completed the ANDA's review cycle, with the next review cycle beginning when the applicant amended the ANDA by submitting a complete response to all deficiencies listed in the CRL. FDA used IRs to ask for information that would assist reviewers during the course of the review or to convey deficiencies identified in the application in advance of a CRL. IRs did not stop the review clock, did not signal the completion of a review cycle, and were not always used consistently across divisions or offices. In negotiations held as part of the Generic Drug User Fee Amendments of 2017 (GDUFA II), it was agreed that FDA will: (1) Issue an IR to request further information or clarification that is needed or would be helpful to allow completion of a discipline review and/or (2) issue a new type of letter for ANDAs, known as a DRL, to convey preliminary thoughts on possible deficiencies found by a discipline reviewer and/or review team for its or their portion of the application under review at the conclusion of a discipline review.\2\ --------------------------------------------------------------------------- \2\ FDA Reauthorization Act of 2017 (FDARA), Public Law 115-52 (2017). FDARA includes GDUFA II, and by reference, the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter). --------------------------------------------------------------------------- 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 ``Information Requests and Discipline Review Letters Under GDUFA.'' 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. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information has been approved under OMB control number 0910-0797. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27124 Filed 12-15-17; 8:45 am] BILLING CODE 4164-01-P
![60018 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
b. Detailed information to determine Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
if the product is calibrated to a Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
recognized standard. following way: Agency will review this copy, including
c. Detailed summary of data • Federal eRulemaking Portal: the claimed confidential information, in
demonstrating suitable analytical and https://www.regulations.gov. Follow the its consideration of comments. The
clinical test characteristics (i.e. instructions for submitting comments. second copy, which will have the
precision, linearity, accuracy, Comments submitted electronically, claimed confidential information
sensitivity/specificity, etc.). including attachments, to https:// redacted/blacked out, will be available
Any collaborations that result from www.regulations.gov will be posted to for public viewing and posted on
these conversations will require that https://www.regulations.gov. Submit
the docket unchanged. Because your
manufacturers enter into an appropriate both copies to the Dockets Management
comment will be made public, you are
agreement prior to the transfer of any Staff. If you do not wish your name and
solely responsible for ensuring that your
material to or from CDC. Sample contact information to be made publicly
comment does not include any
agreements may be viewed at the available, you can provide this
confidential information that you or a
following website: https://www.cdc.gov/ information on the cover sheet and not
third party may not wish to be posted,
od/science/technology/techtransfer/ in the body of your comments and you
such as medical information, your or
researchers/formsagreements/ must identify this information as
anyone else’s Social Security number, or
index.htm. ‘‘confidential.’’ Any information marked
confidential business information, such
All information submitted to CDC will as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
be kept confidential as allowed by that if you include your name, contact
relevant federal law, including the and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
Freedom of Information Act (5 U.S.C. identifies you in the body of your
552) and the Trade Secrets Act (18 of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
U.S.C. 1905). posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
Dated: December 13, 2017. • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
Sandra Cashman, with confidential information that you 23389.pdf.
Executive Secretary, Centers for Disease do not wish to be made available to the Docket: For access to the docket to
Control and Prevention. public, submit the comment as a read background documents or the
[FR Doc. 2017–27189 Filed 12–15–17; 8:45 am] written/paper submission and in the electronic and written/paper comments
BILLING CODE 4163–18–P manner detailed (see ‘‘Written/Paper received, go to https://
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
DEPARTMENT OF HEALTH AND heading of this document, into the
HUMAN SERVICES Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
follows: and/or go to the Dockets Management
Food and Drug Administration • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets Rockville, MD 20852.
[Docket No. FDA–2017–D–6752] Management Staff (HFA–305), Food and You may submit comments on any
Drug Administration, 5630 Fishers guidance at any time (see 21 CFR
Information Requests and Discipline Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)).
Review Letters Under the Generic Drug • For written/paper comments Submit written requests for single
User Fee Amendments; Draft Guidance submitted to the Dockets Management copies of the draft guidance to the
for Industry; Availability Staff, FDA will post your comment, as Division of Drug Information, Center for
well as any attachments, except for Drug Evaluation and Research, Food
AGENCY: Food and Drug Administration,
information submitted, marked and and Drug Administration, 10001 New
HHS.
identified, as confidential, if submitted Hampshire Ave., Hillandale Building,
ACTION: Notice of availability. as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
SUMMARY: The Food and Drug Instructions: All submissions received 0002. Send one self-addressed adhesive
Administration (FDA or Agency) is must include the Docket No. FDA– label to assist that office in processing
announcing the availability of a draft 2017–D–6752 for ‘‘Information Requests your requests. See the SUPPLEMENTARY
guidance for industry entitled and Discipline Review Letters Under INFORMATION section for electronic
‘‘Information Requests and Discipline GDUFA.’’ Received comments will be access to the draft guidance document.
Review Letters Under GDUFA.’’ This placed in the docket and, except for FOR FURTHER INFORMATION CONTACT:
draft guidance explains how FDA will those submitted as ‘‘Confidential Philip Bonforte, Center for Drug
issue and use an information request Submissions,’’ publicly viewable at Evaluation and Research, Food and
(IR) and/or a discipline review letter https://www.regulations.gov or at the Drug Administration, 10903 New
(DRL) during the review of an original Dockets Management Staff between 9 Hampshire Ave., Bldg. 75, Rm. 1668,
abbreviated new drug application a.m. and 4 p.m., Monday through Silver Spring, MD 20993–0002, 240–
(ANDA). Friday. 402–9871, philip.bonforte@fda.hhs.gov.
• Confidential Submissions—To SUPPLEMENTARY INFORMATION:
DATES: Submit either electronic or submit a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance information that you do not wish to be I. Background
by February 16, 2018 to ensure that the made publicly available, submit your FDA is announcing the availability of
Agency considers your comment on this comments only as a written/paper a draft guidance for industry entitled
draft guidance before it begins work on submission. You should submit two ‘‘Information Requests and Discipline
the final version of the guidance. copies total. One copy will include the Review Letters Under GDUFA.’’
ADDRESSES: You may submit comments information you claim to be confidential Under the first iteration of the Generic
on any guidance at any time as follows: with a heading or cover note that states Drug User Fee Amendments of 2012
VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/82_FR_60259/page/1.svg)
![Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60019
(GDUFA I), beginning October 1, 2012, II. Paperwork Reduction Act of 1995 Electronic Submissions
FDA agreed to act on received ANDAs Submit electronic comments in the
This draft guidance refers to
within established time frames. As part following way:
previously approved collections of
of this undertaking, the Agency • Federal eRulemaking Portal:
information found in FDA regulations.
instituted the use of multiple forms of https://www.regulations.gov. Follow the
These collections of information are
communicating with an applicant instructions for submitting comments.
subject to review by the Office of
regarding the review of an application, Comments submitted electronically,
Management and Budget (OMB) under
including issuance of Complete including attachments, to https://
the Paperwork Reduction Act of 1995
Response Letters (CRLs) and IRs.1 www.regulations.gov will be posted to
Under GDUFA I, FDA issued a CRL (44 U.S.C. 3501–3520). The collection of
information has been approved under the docket unchanged. Because your
after completing a review of an ANDA.
OMB control number 0910–0797. comment will be made public, you are
The CRL described all the deficiencies
solely responsible for ensuring that your
identified in the ANDA that must be III. Electronic Access
satisfactorily addressed before the comment does not include any
ANDA can be approved. Issuance of a Persons with access to the internet confidential information that you or a
CRL also completed the ANDA’s review may obtain the draft guidance at either third party may not wish to be posted,
cycle, with the next review cycle https://www.fda.gov/Drugs/Guidance such as medical information, your or
beginning when the applicant amended ComplianceRegulatoryInformation/ anyone else’s Social Security number, or
the ANDA by submitting a complete Guidances/default.htm or https:// confidential business information, such
response to all deficiencies listed in the www.regulations.gov. as a manufacturing process. Please note
CRL. Dated: December 12, 2017. that if you include your name, contact
FDA used IRs to ask for information information, or other information that
Leslie Kux,
that would assist reviewers during the identifies you in the body of your
Associate Commissioner for Policy.
course of the review or to convey comments, that information will be
[FR Doc. 2017–27124 Filed 12–15–17; 8:45 am] posted on https://www.regulations.gov.
deficiencies identified in the
application in advance of a CRL. IRs did
BILLING CODE 4164–01–P • If you want to submit a comment
not stop the review clock, did not signal with confidential information that you
the completion of a review cycle, and do not wish to be made available to the
DEPARTMENT OF HEALTH AND public, submit the comment as a
were not always used consistently HUMAN SERVICES
across divisions or offices. written/paper submission and in the
In negotiations held as part of the Food and Drug Administration manner detailed (see ‘‘Written/Paper
Generic Drug User Fee Amendments of Submissions’’ and ‘‘Instructions’’).
2017 (GDUFA II), it was agreed that Written/Paper Submissions
[Docket No. FDA–2017–D–0759]
FDA will: (1) Issue an IR to request
further information or clarification that Submit written/paper submissions as
Drug Products, Including Biological follows:
is needed or would be helpful to allow Products, That Contain Nanomaterials;
completion of a discipline review and/ • Mail/Hand delivery/Courier (for
Draft Guidance for Industry; written/paper submissions): Dockets
or (2) issue a new type of letter for Availability
ANDAs, known as a DRL, to convey Management Staff (HFA–305), Food and
preliminary thoughts on possible AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
deficiencies found by a discipline HHS. Lane, Rm. 1061, Rockville, MD 20852.
reviewer and/or review team for its or • For written/paper comments
ACTION: Notice of availability.
their portion of the application under submitted to the Dockets Management
review at the conclusion of a discipline SUMMARY: The Food and Drug Staff, FDA will post your comment, as
review.2 Administration (FDA or Agency) is well as any attachments, except for
This draft guidance is being issued announcing the availability of a draft information submitted, marked and
consistent with FDA’s good guidance guidance for industry entitled ‘‘Drug identified, as confidential, if submitted
practices regulation (21 CFR 10.115). Products, Including Biological Products, as detailed in ‘‘Instructions.’’
The draft guidance, when finalized, will that Contain Nanomaterials.’’ This draft Instructions: All submissions received
represent the current thinking of FDA guidance has been developed to provide must include the Docket No. FDA–
on ‘‘Information Requests and industry with the Agency’s current 2017–D–0759 for ‘‘Drug Products,
Discipline Review Letters Under thinking for the development of human Including Biological Products, that
GDUFA.’’ It does not establish any drug products, including those that are Contain Nanomaterials.’’ Received
rights for any person and is not binding biological products, that contain comments will be placed in the docket
on FDA or the public. You can use an nanomaterials. The draft guidance also and, except for those submitted as
alternative approach if it satisfies the includes recommendations for ‘‘Confidential Submissions,’’ publicly
requirements of the applicable statutes applicants and sponsors of viewable at https://www.regulations.gov
and regulations. investigational, premarket, and or at the Dockets Management Staff
postmarket submissions for these between 9 a.m. and 4 p.m., Monday
1 Food and Drug Administration Safety and
products. through Friday.
Innovation Act of 2012 (FDASIA), Public Law 112– Confidential Submissions—To submit
144 (2012). FDASIA includes GDUFA I, and by DATES: Submit either electronic or a comment with confidential
daltland on DSKBBV9HB2PROD with NOTICES
reference, the Generic Drug User Fee Act Program written comments on the draft guidance
Performance Goals and Procedures (GDUFA I information that you do not wish to be
Commitment Letter). by March 19, 2018 to ensure that the made publicly available, submit your
2 FDA Reauthorization Act of 2017 (FDARA), Agency considers your comment on this comments only as a written/paper
Public Law 115–52 (2017). FDARA includes draft guidance before it begins work on submission. You should submit two
GDUFA II, and by reference, the GDUFA the final version of the guidance.
Reauthorization Performance Goals and Program
copies total. One copy will include the
Enhancements Fiscal Years 2018–2022 (GDUFA II ADDRESSES: You may submit comments information you claim to be confidential
Commitment Letter). on any guidance at any time as follows: with a heading or cover note that states
VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1](https://thefederalregister.org/doc/82_FR_60259/page/2.svg)
Document Created: 2017-12-15 23:54:48
Document Modified: 2017-12-15 23:54:48
| 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 the draft guidance by February 16, 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 | Philip Bonforte, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1668, Silver Spring, MD 20993-0002, 240- 402-9871, [email protected] | |
| FR Citation | 82 FR 60018 |
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