82 FR 47531 - Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 196 (October 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47531-47533 | |
| FR Document | 2017-22049 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47531-47533] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-22049] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-5868] Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Requests for Reconsideration at the Division Level Under GDUFA.'' This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of abbreviated new drug applications (ANDAs) that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance also provides information for applicants to consider before pursuing a request for reconsideration, procedures for submitting a request for reconsideration, and the Agency's process for responding to those requests. DATES: Submit either electronic or written comments on the draft guidance by December 11, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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- [[Page 47532]] 2017-D-5868 for ``Requests for Reconsideration at the Division Level Under GDUFA; Draft Guidance for Industry; Availability.'' 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: Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 240-402-6902. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Requests for Reconsideration at the Division Level Under GDUFA.'' This guidance provides recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and applicants of ANDAs that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. In accordance with ``GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022'' (GDUFA II Goals Letter or GDUFA II Commitment Letter; https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM525234.pdf), FDA agreed to certain review goals and procedures for the review of requests for reconsideration received on or after October 1, 2017.\1\ --------------------------------------------------------------------------- \1\ The FDA Reauthorization Act of 2017 (Pub. L. 115-52) included the reauthorization of generic user fees as Title III, Generic Drug User Amendments of 2017 (GDUFA II). --------------------------------------------------------------------------- As agreed to by FDA and industry in the GDUFA II Commitment Letter, applicants may pursue a request for reconsideration within the review discipline at the division level. In addition, if an applicant requests a teleconference as part of its request to reclassify a major amendment or standard review status, FDA will schedule and conduct the teleconference and decide 90 percent of such reclassification requests within 30 days of the date of FDA's receipt of the request for a teleconference. As stated in the GDUFA II Commitment Letter, this goal only applies when the applicant accepts the first scheduled teleconference date offered by FDA. This guidance provides additional details and recommendations concerning considerations for applicants before pursuing a request for reconsideration and procedures for submitting a request for reconsideration and the Agency's process for responding to those requests. 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 ``Requests for Reconsideration at the Division Level 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501- 3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Applications for FDA Approval To Market a New Drug OMB Control Number 0910-0001--Revision The information collection request supports the Agency's draft guidance entitled, ``Requests for Reconsideration at the Division Level Under GDUFA.'' As discussed in section I of this notice, this guidance provides information to respondents regarding procedures for [[Page 47533]] submitting requests for reconsideration, including details on the content and format of the submission. Respondents to the collection of information are applicants of ANDAs. Based on available data with regard to similar information collections, FDA's Center for Drug Evaluation and Research will receive approximately 150 requests for reconsideration annually from 75 respondents. Because we estimate it will take 5 hours to prepare a request for reconsideration, we estimate it will take an average of 750 total hours annually for respondents to prepare and submit requests for reconsideration. The burden of the information collection, therefore, is estimated as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Guidance recommendation Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Section IV: Procedures for Submitting and Responding to a Request 75 2 150 5 750 for Reconsideration............................................... -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital or operating and maintenance costs associated with the collection of information. 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: October 5, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-22049 Filed 10-11-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47531
pharmacists) are not clearly guidance practices regulation (21 CFR (ANDAs) that wish to pursue a request
communicated in REMS documents. 10.115). The revised draft guidance, for reconsideration within the review
Stakeholders have reported spending when finalized, will represent the discipline at the division level or
excessive time trying to locate, current thinking of FDA on the format original signatory authority. This
understand, and comply with REMS and content of a REMS document. It guidance also provides information for
requirements. does not establish any rights for any applicants to consider before pursuing a
To address the stakeholders’ feedback, person and is not binding on FDA or the request for reconsideration, procedures
FDA is revising the 2009 draft guidance public. You can use an alternative for submitting a request for
on the format and content of a REMS to approach if it satisfies the requirements reconsideration, and the Agency’s
include information to assist applicants of the applicable statutes and process for responding to those requests.
in drafting clear, informative, and regulations. This guidance is not subject DATES: Submit either electronic or
standardized REMS documents. This to Executive Order 12866. written comments on the draft guidance
revised draft guidance provides updated by December 11, 2017 to ensure that the
recommendations on the format and II. The Paperwork Reduction Act of
1995 Agency considers your comment on this
content of a REMS document and draft guidance before it begins work on
supersedes the 2009 draft guidance. This revised draft guidance contains the final version of the guidance.
Additional and more detailed information collection provisions that
information is provided in the template ADDRESSES: You may submit comments
are subject to review by the Office of
appended to this guidance. Management and Budget (OMB) under on any guidance at any time as follows:
The new format of the REMS the Paperwork Reduction Act of 1995 Electronic Submissions
document, as described in this revised (44 U.S.C. 3501–3520). The collection of
draft guidance and appended template, Submit electronic comments in the
information in the guidance was
contains substantially the same content following way:
approved under OMB control numbers
as described in the 2009 draft guidance; • Federal eRulemaking Portal:
0910–0001 and 0910–0338.
however, the information has been https://www.regulations.gov. Follow the
reorganized. In the old format, the III. Electronic Access instructions for submitting comments.
REMS requirements were organized by Persons with access to the internet Comments submitted electronically,
the elements described in the statute. In may obtain the draft guidance at either including attachments, to https://
the new format, requirements are https://www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to
organized to describe who is responsible ComplianceRegulatoryInformation/ the docket unchanged. Because your
for implementing the requirement, Guidances/default.htm, https:// comment will be made public, you are
when the requirement is to be www.fda.gov/BiologicsBloodVaccines/ solely responsible for ensuring that your
implemented, what the required action GuidanceComplianceRegulatory comment does not include any
is, and with what REMS material(s). Information/Guidances/default.htm, or confidential information that you or a
Additionally, the new format supports https://www.regulations.gov. third party may not wish to be posted,
submission of REMS documents in such as medical information, your or
Dated: October 5, 2017.
Structured Product Labeling (SPL) anyone else’s Social Security number, or
Anna K. Abram, confidential business information, such
format. Deputy Commissioner for Policy, Planning,
Certain information included in the as a manufacturing process. Please note
Legislation, and Analysis. that if you include your name, contact
2009 draft guidance has been revised
[FR Doc. 2017–22050 Filed 10–11–17; 8:45 am] information, or other information that
and included in other guidances
subsequently published and therefore BILLING CODE 4164–01–P identifies you in the body of your
has been omitted from this revised draft comments, that information will be
guidance. For example: posted on https://www.regulations.gov.
DEPARTMENT OF HEALTH AND • If you want to submit a comment
• Information on how FDA
HUMAN SERVICES with confidential information that you
determines when a REMS is necessary
to ensure that the benefits of a drug Food and Drug Administration do not wish to be made available to the
outweigh its risks can be found in the public, submit the comment as a
draft guidance for industry, ‘‘FDA’s [Docket No. FDA–2017–D–5868] written/paper submission and in the
Application of Statutory Factors in manner detailed (see ‘‘Written/Paper
Requests for Reconsideration at the Submissions’’ and ‘‘Instructions’’).
Determining When a REMS Is
Division Level Under the Generic Drug
Necessary’’ (at: https://www.fda.gov/ Written/Paper Submissions
User Fee Act; Draft Guidance for
ucm/groups/fdagov-public/@fdagov-
Industry; Availability Submit written/paper submissions as
drugs-gen/documents/document/
ucm521504.pdf). AGENCY: Food and Drug Administration, follows:
• Information on REMS modifications HHS. • Mail/Hand delivery/Courier (for
can be found in the guidance for ACTION: Notice of availability. written/paper submissions): Dockets
industry, ‘‘Risk Evaluation and Management Staff (HFA–305), Food and
Mitigation Strategies: Modifications and SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
Revisions’’ (at: https://www.fda.gov/ Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
downloads/drugs/guidancecompliance announcing the availability of a draft
regulatoryinformation/guidances/ guidance for industry entitled ‘‘Requests submitted to the Dockets Management
ucm441226.pdf). for Reconsideration at the Division Staff, FDA will post your comment, as
This revised guidance and appended Level Under GDUFA.’’ This guidance well as any attachments, except for
template are being reissued in draft form provides recommendations for industry information submitted, marked and
to enable the public to review and on the procedures for resolving identified, as confidential, if submitted
comment before finalization. scientific and/or regulatory issues or as detailed in ‘‘Instructions.’’
This revised draft guidance is being matters between FDA and applicants of Instructions: All submissions received
issued consistent with FDA’s good abbreviated new drug applications must include the Docket No. FDA–
VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/82_FR_47727/page/1.svg)
![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47533
submitting requests for reconsideration, information collections, FDA’s Center reconsideration, we estimate it will take
including details on the content and for Drug Evaluation and Research will an average of 750 total hours annually
format of the submission. Respondents receive approximately 150 requests for for respondents to prepare and submit
to the collection of information are reconsideration annually from 75 requests for reconsideration. The burden
applicants of ANDAs. Based on respondents. Because we estimate it will of the information collection, therefore,
available data with regard to similar take 5 hours to prepare a request for is estimated as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Guidance recommendation responses per burden per
respondents responses hours
respondent response
Section IV: Procedures for Submitting and Responding to
a Request for Reconsideration ........................................ 75 2 150 5 750
1 There are no capital or operating and maintenance costs associated with the collection of information.
III. Electronic Access DATES: Fax written comments on the identity for food ‘‘whenever . . . such
Persons with access to the Internet collection of information by November action will promote honesty and fair
may obtain the draft guidance at either 13, 2017. dealing in the interest of consumers
https://www.fda.gov/Drugs/ ADDRESSES: To ensure that comments on . . . .’’ Under section 403(g) of the
GuidanceCompliance the information collection are received, FD&C Act (21 U.S.C. 343(g)), a food that
RegulatoryInformation/Guidances/ OMB recommends that written is subject to a definition and standard of
default.htm or https://www.regulations comments be faxed to the Office of identity prescribed by regulation is
.gov. Information and Regulatory Affairs, misbranded if it does not conform to
OMB, Attn: FDA Desk Officer, Fax: 202– such definition and standard of identity.
Dated: October 5, 2017. Section 130.17 (21 CFR 130.17) provides
395–7285, or emailed to oira_
Anna K. Abram, for the issuance by FDA of temporary
submission@omb.eop.gov. All
Deputy Commissioner for Policy, Planning, comments should be identified with the marketing permits that enable the food
Legislation, and Analysis. industry to test consumer acceptance
OMB control number 0910–0133. Also
[FR Doc. 2017–22049 Filed 10–11–17; 8:45 am] include the FDA docket number found and measure the technological and
BILLING CODE 4164–01–P in brackets in the heading of this commercial feasibility in interstate
document. commerce of experimental packs of food
that deviate from applicable definitions
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: Ila and standards of identity. Section
HUMAN SERVICES Mizrachi, Office of Operations, Food 130.17(c) enables the Agency to monitor
and Drug Administration, Three White the manufacture, labeling, and
Food and Drug Administration Flint North, 10–12M, 11601 Landsdown distribution of experimental packs of
[Docket No. FDA–2011–N–0424] St., North Bethesda, MD 20852, 301– food that deviate from applicable
796–7729, PRAStaff@fda.hhs.gov. definitions and standards of identity.
Agency Information Collection SUPPLEMENTARY INFORMATION: In The information so obtained can be
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA used in support of a petition to establish
Management and Budget Review; has submitted the following proposed or amend the applicable definition or
Comment Request; Temporary collection of information to OMB for standard of identity to provide for the
Marketing Permit Applications review and clearance. variations. Section 130.17(i) specifies
AGENCY: Food and Drug Administration, Temporary Marketing Permit the information that a firm must submit
HHS. Applications—21 CFR 130.17(c) and (i) to FDA to obtain an extension of a
temporary marketing permit.
ACTION: Notice. OMB Control Number 0910–0133— In the Federal Register of June 15,
SUMMARY: The Food and Drug Extension 2017 (82 FR 27489), we published a 60-
Administration (FDA) is announcing This information collection supports day notice requesting public comment
that a proposed collection of Agency regulations. Specifically, section on the proposed extension of this
information has been submitted to the 401 of the Federal Food, Drug, and collection of information. No comments
Office of Management and Budget Cosmetic Act (the FD&C Act) (21 U.S.C. were received.
(OMB) for review and clearance under 341) directs FDA to issue regulations We therefore estimate the burden of
the Paperwork Reduction Act of 1995. establishing definitions and standards of this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden Total hours
respondents responses
respondent per response
130.17(c)—Request for temporary marketing permit .......... 13 2 26 25 650
130.17(i)—Request to extend marketing permit .................. 1 2 2 2 4
Total .............................................................................. ........................ ........................ ........................ ........................ 654
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\12OCN1.SGM 12OCN1](https://thefederalregister.org/doc/82_FR_47727/page/3.svg)
Document Created: 2018-10-25 10:05:12
Document Modified: 2018-10-25 10:05:12
| 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 December 11, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 240-402-6902. | |
| FR Citation | 82 FR 47531 |
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