Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability, 47531-47533 [2017-22049]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with NOTICES Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices pharmacists) are not clearly communicated in REMS documents. Stakeholders have reported spending excessive time trying to locate, understand, and comply with REMS requirements. To address the stakeholders’ feedback, FDA is revising the 2009 draft guidance on the format and content of a REMS to include information to assist applicants in drafting clear, informative, and standardized REMS documents. This revised draft guidance provides updated recommendations on the format and content of a REMS document and supersedes the 2009 draft guidance. Additional and more detailed information is provided in the template appended to this guidance. The new format of the REMS document, as described in this revised draft guidance and appended template, contains substantially the same content as described in the 2009 draft guidance; however, the information has been reorganized. In the old format, the REMS requirements were organized by the elements described in the statute. In the new format, requirements are organized to describe who is responsible for implementing the requirement, when the requirement is to be implemented, what the required action is, and with what REMS material(s). Additionally, the new format supports submission of REMS documents in Structured Product Labeling (SPL) format. Certain information included in the 2009 draft guidance has been revised and included in other guidances subsequently published and therefore has been omitted from this revised draft guidance. For example: • Information on how FDA determines when a REMS is necessary to ensure that the benefits of a drug outweigh its risks can be found in the draft guidance for industry, ‘‘FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary’’ (at: https://www.fda.gov/ ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/ ucm521504.pdf). • Information on REMS modifications can be found in the guidance for industry, ‘‘Risk Evaluation and Mitigation Strategies: Modifications and Revisions’’ (at: https://www.fda.gov/ downloads/drugs/guidancecompliance regulatoryinformation/guidances/ ucm441226.pdf). This revised guidance and appended template are being reissued in draft form to enable the public to review and comment before finalization. This revised draft guidance is being issued consistent with FDA’s good VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on the format and content of a REMS document. 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. The Paperwork Reduction Act of 1995 This revised draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collection of information in the guidance was approved under OMB control numbers 0910–0001 and 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/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. 2017–22050 Filed 10–11–17; 8:45 am] BILLING CODE 4164–01–P 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. 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 SUMMARY: PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 47531 (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– E:\FR\FM\12OCN1.SGM 12OCN1 47532 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices asabaliauskas on DSKBBXCHB2PROD with NOTICES 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 your requests. See the SUPPLEMENTARY 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: 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 THIS DOCUMENT CONTAINS CONFIDENTIAL ANDAs that wish to pursue a request for INFORMATION. The Agency will review reconsideration within the review this copy, including the claimed discipline at the division level or confidential information, in its original signatory authority. In consideration of comments. The second accordance with ‘‘GDUFA copy, which will have the claimed Reauthorization Performance Goals and confidential information redacted/ Program Enhancements Fiscal Years blacked out, will be available for public 2018–2022’’ (GDUFA II Goals Letter or viewing and posted on https:// GDUFA II Commitment Letter; https:// www.regulations.gov. Submit both www.fda.gov/downloads/ForIndustry/ copies to the Dockets Management Staff. UserFees/GenericDrugUserFees/ If you do not wish your name and UCM525234.pdf), FDA agreed to certain contact information to be made publicly review goals and procedures for the available, you can provide this review of requests for reconsideration information on the cover sheet and not received on or after October 1, 2017.1 in the body of your comments and you As agreed to by FDA and industry in must identify this information as the GDUFA II Commitment Letter, ‘‘confidential.’’ Any information marked applicants may pursue a request for as ‘‘confidential’’ will not be disclosed reconsideration within the review except in accordance with 21 CFR 10.20 discipline at the division level. In and other applicable disclosure law. For addition, if an applicant requests a more information about FDA’s posting teleconference as part of its request to of comments to public dockets, see 80 reclassify a major amendment or FR 56469, September 18, 2015, or access standard review status, FDA will the information at: https://www.gpo.gov/ schedule and conduct the fdsys/pkg/FR-2015-09-18/pdf/2015teleconference and decide 90 percent of 23389.pdf. such reclassification requests within 30 Docket: For access to the docket to days of the date of FDA’s receipt of the read background documents or the request for a teleconference. As stated in electronic and written/paper comments the GDUFA II Commitment Letter, this received, go to https:// goal only applies when the applicant www.regulations.gov and insert the accepts the first scheduled docket number, found in brackets in the teleconference date offered by FDA. heading of this document, into the This guidance provides additional ‘‘Search’’ box and follow the prompts details and recommendations and/or go to the Dockets Management concerning considerations for Staff, 5630 Fishers Lane, Rm. 1061, applicants before pursuing a request for Rockville, MD 20852. reconsideration and procedures for You may submit comments on any submitting a request for reconsideration guidance at any time (see 21 CFR and the Agency’s process for responding 10.115(g)(5)). to those requests. Submit written requests for single This draft guidance is being issued copies of the draft guidance to the Division of Drug Information, Center for consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Drug Evaluation and Research, Food The draft guidance, when finalized, will and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 1 The FDA Reauthorization Act of 2017 (Pub. L. 4th Floor, Silver Spring, MD 20993– 115–52) included the reauthorization of generic 0002. Send one self-addressed adhesive user fees as Title III, Generic Drug User Amendments of 2017 (GDUFA II). label to assist that office in processing VerDate Sep<11>2014 22:35 Oct 11, 2017 Jkt 244001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12OCN1.SGM 12OCN1 47533 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 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 Guidance recommendation Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 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 Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/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 Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7729, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0424] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications AGENCY: Food and Drug Administration, HHS. ACTION: Fax written comments on the collection of information by November 13, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0133. Also include the FDA docket number found in brackets in the heading of this document. DATES: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. SUMMARY: Temporary Marketing Permit Applications—21 CFR 130.17(c) and (i) OMB Control Number 0910–0133— Extension This information collection supports Agency regulations. Specifically, section 401 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 341) directs FDA to issue regulations establishing definitions and standards of identity for food ‘‘whenever . . . such action will promote honesty and fair dealing in the interest of consumers . . . .’’ Under section 403(g) of the FD&C Act (21 U.S.C. 343(g)), a food that is subject to a definition and standard of identity prescribed by regulation is misbranded if it does not conform to such definition and standard of identity. Section 130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary marketing permits that enable the food industry to test consumer acceptance and measure the technological and commercial feasibility in interstate commerce of experimental packs of food that deviate from applicable definitions and standards of identity. Section 130.17(c) enables the Agency to monitor the manufacture, labeling, and distribution of experimental packs of food that deviate from applicable definitions and standards of identity. The information so obtained can be used in support of a petition to establish or amend the applicable definition or standard of identity to provide for the variations. Section 130.17(i) specifies the information that a firm must submit to FDA to obtain an extension of a temporary marketing permit. In the Federal Register of June 15, 2017 (82 FR 27489), we published a 60day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We therefore estimate the burden of this collection of information as follows: asabaliauskas on DSKBBXCHB2PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 130.17(c)—Request for temporary marketing permit .......... 130.17(i)—Request to extend marketing permit .................. 13 1 2 2 26 2 25 2 650 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

Agencies

[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Pages 47531-47533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.gpo.gov/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
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