Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 51424-51425 [2017-24121]

Download as PDF 51424 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices ANDA submissions, as well as the presubmission certification statement (referenced in table 1), takes into consideration that much of this content is related to information already gathered for the ANDA submission. We invite comments on these estimates. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Pre-Submission of Facility Information ................................ Certification statement submitted with the ANDA ............... 1 There Number of responses per respondent 220 198 Total annual responses 1.25 1.25 275 248 Average burden per response Total hours 1.1 4 303 990 are no capital costs or operating and maintenance costs associated with this collection of information. 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 Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https://www. regulations.gov. Dated: October 31, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24099 Filed 11–3–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2010–N–0258; FDA– 2010–N–0623; FDA–2007–N–0383; FDA– 2009–N–0360; FDA–2016–N–4620; FDA– 2013–N–1496; FDA–2007–N–0220; FDA– 2017–N–1848; FDA–2017–N–1066; FDA– 2015–D–3327; FDA–2011–D–0689] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. SUPPLEMENTARY INFORMATION: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Pmangrum on DSK3GDR082PROD with NOTICES Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission to Information to a Master File in Support of Petitions; and Electronic Submission Using FDA 3053 ............................................. Voluntary Cosmetic Registration Program .............................................................................................................. Radioactive Drug Research Committees ................................................................................................................ FDA Safety Communication Readership Survey .................................................................................................... Medical Devices; Reports for Corrections and Removals ...................................................................................... Generic FDA Rapid Response Surveys .................................................................................................................. Guidance for Industry: Pharmacogenomic Data Submissions ................................................................................ Cosmetic Labeling Regulations ............................................................................................................................... Annual Reporting for Custom Device Exemption .................................................................................................... GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation ....................................................... DeNovo Classification Process (Evaluation of Automatic Class II Designation) .................................................... Dated: November 1, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24121 Filed 11–3–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:12 Nov 03, 2017 Jkt 244001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1 0910–0016 0910–0027 0910–0053 0910–0341 0910–0359 0910–0500 0910–0557 0910–0599 0910–0767 0910–0843 0910–0844 Date approval expires 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 9/30/2020 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0403] Agency Information Collection Activities; Proposed Collection; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the guidance entitled ‘‘Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.’’ DATES: Submit either electronic or written comments on the collection of information by January 5, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 5, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: Pmangrum on DSK3GDR082PROD with NOTICES 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 VerDate Sep<11>2014 18:12 Nov 03, 2017 Jkt 244001 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– 2011–N–0403 for ‘‘Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act.’’ Received comments, those filed in a timely manner (see ADDRESSES), 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 51425 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/201523389.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. Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Under the 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. SUPPLEMENTARY INFORMATION: E:\FR\FM\06NON1.SGM 06NON1

Agencies

[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51424-51425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-N-0258; FDA-2010-N-0623; FDA-2007-N-0383; FDA-
2009-N-0360; FDA-2016-N-4620; FDA-2013-N-1496; FDA-2007-N-0220; FDA-
2017-N-1848; FDA-2017-N-1066; FDA-2015-D-3327; FDA-2011-D-0689]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Submission of Petitions: Food Additive,        0910-0016       9/30/2020
 Color Additive (Including Labeling),
 Submission to Information to a Master
 File in Support of Petitions; and
 Electronic Submission Using FDA 3053...
Voluntary Cosmetic Registration Program.       0910-0027       9/30/2020
Radioactive Drug Research Committees....       0910-0053       9/30/2020
FDA Safety Communication Readership            0910-0341       9/30/2020
 Survey.................................
Medical Devices; Reports for Corrections       0910-0359       9/30/2020
 and Removals...........................
Generic FDA Rapid Response Surveys......       0910-0500       9/30/2020
Guidance for Industry: Pharmacogenomic         0910-0557       9/30/2020
 Data Submissions.......................
Cosmetic Labeling Regulations...........       0910-0599       9/30/2020
Annual Reporting for Custom Device             0910-0767       9/30/2020
 Exemption..............................
GFI: E6(R2) Good Clinical Practice;            0910-0843       9/30/2020
 International Council for Harmonisation
DeNovo Classification Process                  0910-0844       9/30/2020
 (Evaluation of Automatic Class II
 Designation)...........................
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    Dated: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24121 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P