Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 60093-60094 [2019-24263]

Download as PDF Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices 1. Christian J. Ryan, Byron, Minnesota; to acquire voting shares of Olmsted Bancorporation, Inc., and thereby indirectly acquire voting shares of First Security Bank, both of Byron, Minnesota. Board of Governors of the Federal Reserve System, November 1, 2019. Michele Taylor Fennell, Assistant Secretary of the Board. [FR Doc. 2019–24241 Filed 11–6–19; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below). DATES: The meeting will be held on December 11, 2019 from 8:15 a.m. to 5:30 p.m., PST. A public comment session will be held on December 11, 2019 at 5:30 p.m., PST and conclude at 6:30 p.m., PST or following the final call for public comment, whichever comes first. SUMMARY: Hilton Oakland Airport Hotel, One Hegenberger Road, Oakland, California 94621; Phone: (510) 635– 5000, Fax: (510) 383–4090. The public may join the audio conference call via FTS Conferencing. The USA toll-free dial-in number is 1–866–659–0537; and the pass code is 9933701. The meeting will also be accessible via Web conference by Skype: meeting ADDRESSES: VerDate Sep<11>2014 17:55 Nov 06, 2019 Jkt 250001 CONNECTION: https:// webconf.cdc.gov/zab6/yzdq02pl?sl=1. FOR FURTHER INFORMATION CONTACT: Theodore Katz, MPA, Designated Federal Officer, NIOSH, CDC, 1600 Clifton Road, Mailstop E–20, Atlanta, Georgia 30329–4027, Telephone (513) 533–6800, Toll Free 1 (800) CDC–INFO, Email ocas@cdc.gov. SUPPLEMENTARY INFORMATION: BACKGROUND: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The Advisory Board’s charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered on February 12, 2018, and will terminate on February 12, 2020. PURPOSE: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. MATTERS TO BE CONSIDERED: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 60093 SEC Petitions Update; Completed Site Profile Reviews; Draft Report to the Secretary, HHS on Dose Reconstruction Reviews, Coworker Modeling Guidelines Review; SEC Petition Review Update for Savannah River Site (Aiken, South Carolina, 1972–2007); Lawrence Berkeley National Laboratory Site Profile Review Update; and a Board Work Session. Agenda items are subject to change as priorities dictate. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Control and Prevention and the Agency for Toxic Substances and Disease Registry. Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–24244 Filed 11–6–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–N–0375, FDA– 2013–N–0520, FDA–2008–D–0031, FDA– 2012–N–0386, FDA–2013–N–0377, FDA– 2011–D–0147, FDA–2013–N–1588, FDA– 2013–N–0093, and FDA–2016–N–1593] 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. 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. SUMMARY: 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 SUPPLEMENTARY INFORMATION: E:\FR\FM\07NON1.SGM 07NON1 60094 Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices 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 No. Title of Collection Agreement for Shipment of Devices for Sterilization .............................................................................................. Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed .......... Clinical Laboratory Improvement Amendments Waiver Applications ..................................................................... Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products ......................................................................................................... Tobacco Health Document Submission .................................................................................................................. Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence Requirements for Tobacco Products .................................................................................. Exemptions From Substantial Equivalence Requirements for Tobacco Products ................................................. Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilars User Fee Act .................................................................... Medical Device Accessories .................................................................................................................................... Dated: October 29, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. comment on the draft best practices in drug and biological product postmarket safety surveillance. [FR Doc. 2019–24263 Filed 11–6–19; 8:45 am] DATES: Submit either electronic or written comments on the draft document by January 6, 2020 to ensure that the Agency considers your comment on this draft document before it begins work on the final version. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ADDRESSES: Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Availability; Establishment of Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of availability; establishment of public docket; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a draft document that details best practices for drug safety surveillance entitled ‘‘Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.’’ The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA make publicly available on its internet website best practices for drug safety surveillance activities. The draft document sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. FDA is seeking public SUMMARY: VerDate Sep<11>2014 17:55 Nov 06, 2019 Jkt 250001 You may submit comments as follows: [Docket No. FDA–2019–N–3768] 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’’). PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Date approval expires 0910–0131 0910–0339 0910–0598 9/30/2022 9/30/2022 9/30/2022 0910–0650 0910–0654 9/30/2022 9/30/2022 0910–0673 0910–0684 9/30/2022 9/30/2022 0910–0746 0910–0823 9/30/2022 9/30/2022 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– 2019–N–3768 for ‘‘Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.’’ 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 E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60093-60094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-0375, FDA-2013-N-0520, FDA-2008-D-0031, FDA-
2012-N-0386, FDA-2013-N-0377, FDA-2011-D-0147, FDA-2013-N-1588, FDA-
2013-N-0093, and FDA-2016-N-1593]


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, 
[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

[[Page 60094]]

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
------------------------------------------------------------------------
Agreement for Shipment of Devices for          0910-0131       9/30/2022
 Sterilization..........................
Substances Prohibited from Use in Animal       0910-0339       9/30/2022
 Food or Feed; Animal Proteins
 Prohibited in Ruminant Feed............
Clinical Laboratory Improvement                0910-0598       9/30/2022
 Amendments Waiver Applications.........
Registration and Product Listing for           0910-0650       9/30/2022
 Owners and Operators of Domestic
 Tobacco Product Establishments and
 Listing of Ingredients in Tobacco
 Products...............................
Tobacco Health Document Submission......       0910-0654       9/30/2022
Guidance for Industry and Food and Drug        0910-0673       9/30/2022
 Administration Staff; Section 905(j)
 Reports: Demonstrating Substantial
 Equivalence Requirements for Tobacco
 Products...............................
Exemptions From Substantial Equivalence        0910-0684       9/30/2022
 Requirements for Tobacco Products......
Evaluation of the Program for Enhanced         0910-0746       9/30/2022
 Review Transparency and Communication
 for New Molecular Entity New Drug
 Applications and Original Biologics
 License Applications in Prescription
 Drug User Fee Acts and 351(k) Biologics
 License Applications in Biosimilars
 User Fee Act...........................
Medical Device Accessories..............       0910-0823       9/30/2022
------------------------------------------------------------------------


    Dated: October 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24263 Filed 11-6-19; 8:45 am]
 BILLING CODE 4164-01-P