Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 15187-15188 [2020-05354]

Download as PDF 15187 Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices ANNUAL BURDEN ESTIMATES—Continued Total number of respondents Instrument Annual number of respondents Number of responses per respondent Average burden hours per response Annual burden hours PHASE 2 ESTIMATES First follow-up survey—participants ..................................... Second follow-up survey—participants ................................ Service receipt tracking—program staff .............................. Staff characteristics survey—program staff ......................... Program leadership survey—program leaders .................... Semi-structured program discussion guide—program leaders ..................................................................................... Semi-structured program discussion guide—program supervisors and partners ..................................................... Semi-structured program discussion guide—program staff, providers ........................................................................... Semi-structured employer discussion guide—employers .... In-depth participant interview guide—participants ............... Cost workbook—program staff ............................................ 8,000 8,000 200 200 50 2,667 2,667 67 67 17 1 1 250 1 1 0.83 0.83 0.08 0.42 0.25 2,214 2,214 1,340 28 4 40 13 1 1.5 20 80 27 1 1.0 27 80 50 200 40 27 17 67 13 1 1 1 1 0.75 1.0 2.0 32.0 20 17 134 416 Estimated Total Annual Burden Hours, Phase 2: ........ ........................ ........................ ........................ ........................ 6,434 Authority: Section 413 of the Social Security Act, as amended by the FY 2017 Consolidated Appropriations Act, 2017 (Public Law 115–31). DEPARTMENT OF HEALTH AND HUMAN SERVICES Mary B. Jones, ACF/OPRE Certifying Officer. [Docket Nos. FDA–2019–N–3077; FDA– 2013–N–0403; FDA–2013–N–0579; FDA– 2016–N–2474; FDA–2013–N–0717; FDA– 2018–N–3728; FDA–2013–N–0797; FDA– 2013–N–0578; FDA–2013–N–0879; FDA– 2012–N–0197; FDA–2016–N–3586; FDA– 2016–N–4319; and FDA–2013–N–0764] [FR Doc. 2020–05440 Filed 3–16–20; 8:45 am] BILLING CODE 4184–09–P Food and Drug Administration 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. khammond on DSKJM1Z7X2PROD with NOTICES Title of collection Obtaining Information to Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities ............................................................................................................................................................... Protection of Human Subjects; Informed Consent; and Institutional Boards .......................................................... Biological Products: Reporting and Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing ......................................................................................................... Reporting Associated with Designated New Animal Drugs for Minor Use and Minor Species .............................. Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaign .......... Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs ................................................................................................................ Human Tissue Intended for Transplantation ........................................................................................................... General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h ............................. Procedures for the Safe Processing and Importing of Fish and Fishery Products ................................................ Medical Devices; Shortages Data Collection System ............................................................................................. Focus Groups About Drug Products as Used by the Food and Drug Administration ............................................ VerDate Sep<11>2014 17:32 Mar 16, 2020 Jkt 250001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1 Date approval expires 0910–0883 0910–0130 1/31/2021 1/31/2023 0910–0458 0910–0605 0910–0753 1/31/2023 1/31/2023 1/31/2023 0910–0882 0910–0302 1/31/2023 2/28/2023 0910–0338 0910–0354 0910–0491 0910–0677 2/28/2023 2/28/2023 2/28/2023 2/28/2023 15188 Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued OMB Control No. Title of collection Unique Device Identification System ....................................................................................................................... Animal Feed Regulatory Program Standards ......................................................................................................... Dated: March 11, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 18, 2020. 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. Food and Drug Administration Electronic Submissions [FR Doc. 2020–05354 Filed 3–16–20; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2020–N–0908] Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 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 FDA’s regulations for submission of petitions, including food and color additive petitions (FAPs and CAPs) (including labeling) submission of information to a master file in support of petitions, and electronic submission using Form FDA 3503. DATES: Submit either electronic or written comments on the collection of information by May 18, 2020. 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 May 18, 2020. The https://www.regulations.gov khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:32 Mar 16, 2020 Jkt 250001 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– PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 0910–0720 0910–0760 Date approval expires 2/28/2023 2/28/2023 2020–N–0908 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503.’’ 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 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.govinfo.gov/content/pkg/FR-201509-18/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 E:\FR\FM\17MRN1.SGM 17MRN1

Agencies

[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15187-15188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-N-3077; FDA-2013-N-0403; FDA-2013-N-0579; FDA-
2016-N-2474; FDA-2013-N-0717; FDA-2018-N-3728; FDA-2013-N-0797; FDA-
2013-N-0578; FDA-2013-N-0879; FDA-2012-N-0197; FDA-2016-N-3586; FDA-
2016-N-4319; and FDA-2013-N-0764]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, 
[email protected].

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
------------------------------------------------------------------------
Obtaining Information to Understand            0910-0883       1/31/2021
 Challenges and Opportunities
 Encountered by Compounding Outsourcing
 Facilities.............................
Protection of Human Subjects; Informed         0910-0130       1/31/2023
 Consent; and Institutional Boards......
Biological Products: Reporting and             0910-0458       1/31/2023
 Biological Product Deviations and Human
 Cells, Tissues, and Cellular and Tissue-
 Based Deviations in Manufacturing......
Reporting Associated with Designated New       0910-0605       1/31/2023
 Animal Drugs for Minor Use and Minor
 Species................................
Evaluation of the Food and Drug                0910-0753       1/31/2023
 Administration's General Market Youth
 Tobacco Prevention Campaign............
Collection of Conflict of Interest             0910-0882       1/31/2023
 Information for Participation in Food
 and Drug Administration Non-Employee
 Fellowship and Traineeship Programs....
Human Tissue Intended for                      0910-0302       2/28/2023
 Transplantation........................
General Licensing Provisions: Biologics        0910-0338       2/28/2023
 License Application, Changes to an
 Approved Application, Labeling,
 Revocation and Suspension,
 Postmarketing Studies Status Reports,
 and Form FDA 356h......................
Procedures for the Safe Processing and         0910-0354       2/28/2023
 Importing of Fish and Fishery Products.
Medical Devices; Shortages Data                0910-0491       2/28/2023
 Collection System......................
Focus Groups About Drug Products as Used       0910-0677       2/28/2023
 by the Food and Drug Administration....

[[Page 15188]]

 
Unique Device Identification System.....       0910-0720       2/28/2023
Animal Feed Regulatory Program Standards       0910-0760       2/28/2023
------------------------------------------------------------------------


    Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05354 Filed 3-16-20; 8:45 am]
 BILLING CODE 4164-01-P

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