Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Radiation Exposure Screening and Education Program, OMB No. 0906-0012-Extension

• Published date: 30 October 2020
• Citation: 85 FR 68889
• Record Number: 2020-24122
• Section: Notices
• Court: Health Resources And Services Administration

68889

Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices

Application No. Drug Applicant

ANDA 210681 ...................... Ranitidine HCl Capsules, EQ 150 mg base and EQ 300

mg base. Novitium Pharma LLC, 70 Lake Dr., East Windsor, NJ

08520.

Therefore, approval of the

applications listed in the table, and all

amendments and supplements thereto,

is hereby withdrawn as of November 30,

2020. Approval of each entire

application is withdrawn, including any

strengths and dosage forms

inadvertently missing from the table.

Introduction or delivery for introduction

into interstate commerce of products

without approved new drug

applications violates section 301(a) and

(d) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 331(a) and (d)).

Drug products that are listed in the table

that are in inventory on November 30,

2020 may continue to be dispensed

until the inventories have been depleted

or the drug products have reached their

expiration dates or otherwise become

violative, whichever occurs first.

Dated: October 26, 2020.

Lauren K. Roth,

Acting Principal Associate Commissioner for

Policy.

[FR Doc. 2020–24012 Filed 10–29–20; 8:45 am]

BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection: Public

Comment Request; Information

Collection Request Title: Radiation

Exposure Screening and Education

Program, OMB No. 0906–0012—

Extension

AGENCY

: Health Resources and Services

Administration (HRSA), Department of

Health and Human Services.

ACTION

: Notice.

SUMMARY

: In compliance with the

requirement for opportunity for public

comment on proposed data collection

projects of the Paperwork Reduction Act

of 1995, HRSA announces plans to

submit an Information Collection

Request (ICR), described below, to the

Office of Management and Budget

(OMB). Prior to submitting the ICR to

OMB, HRSA seeks comments from the

public regarding the burden estimate,

below, or any other aspect of the ICR.

DATES

: Comments on this ICR should be

received no later than December 29,

2020.

ADDRESSES

: Submit your comments to

paperwork@hrsa.gov or mail the HRSA

Information Collection Clearance

Officer, Room 14N136B, 5600 Fishers

Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT

: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, email paperwork@hrsa.gov

or call Lisa Wright-Solomon, the HRSA

Information Collection Clearance Officer

at (301) 443–1984.

SUPPLEMENTARY INFORMATION

: When

submitting comments or requesting

information, please include the

information request collection title for

reference.

Information Collection Request Title:

Radiation Exposure Screening and

Education Program, OMB No. 0906–

0012—Extension.

Abstract: The Radiation Exposure

Screening and Education Program

(RESEP) is authorized by section 417C

of the Public Health Service Act (42

U.S.C. 285a–9). The purpose of RESEP

is to assist individuals who live (or

lived) in areas where U.S. nuclear

weapons testing occurred and who are

diagnosed with cancer and other

radiogenic diseases caused by exposure

to nuclear fallout or nuclear materials

such as uranium. RESEP funds support

eligible health care organizations in:

Implementing cancer screening

programs; developing education

programs; disseminating information on

radiogenic diseases and the importance

of early detection; screening eligible

individuals for cancer and other

radiogenic diseases; providing

appropriate referrals for medical

treatment; and facilitating

documentation of Radiation Exposure.

Need and Proposed Use of the

Information: For this program,

performance measures were drafted to

provide data useful to the program and

to enable HRSA to provide aggregate

program data required by Congress

under the Government Performance and

Results Act of 1993 (Pub. L. 103–62).

These measures cover the principal

topic areas of interest to the Federal

Office of Rural Health Policy, including:

(a) Demographics for the RESEP

program user population; (b) medical

screening activities for cancers and

other radiogenic diseases; (c) exposure

and presentation types for eligible

radiogenic malignant and nonmalignant

diseases; (d) referrals for appropriate

medical treatment; (e) eligibility

counseling and referral assistance for

the RECA; and (f) program outreach and

education activities. These measures

will speak to the Office’s progress

toward meeting the goals set.

Likely Respondents: Radiation

Exposure Screening and Education

Program award recipients.

Burden Statement: Burden in this

context means the time expended by

persons to generate, maintain, retain,

disclose or provide the information

requested. This includes the time

needed to: Review instructions; to

develop, acquire, install and utilize

technology and systems for the purpose

of collecting, validating and verifying

information, processing and

maintaining information, and disclosing

and providing information; to train

personnel and to be able to respond to

a collection of information; to search

data sources; to complete and review

the collection of information; and to

transmit or otherwise disclose the

information. The total annual burden

hours estimated for this ICR are

summarized in the table below.

T

OTAL

E

STIMATED

A

NNUALIZED

B

URDEN

H

OURS

Form name Number of

respondents

Number of

responses per

respondent

Total

responses

Average

burden per

response

(in hours)

Total burden

hours

Radiation Expose Screening and Education Program ........ 8 1 8 12 96

8 ........................ 8 ........................ 96

VerDate Sep<11>2014 21:10 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

jbell on DSKJLSW7X2PROD with NOTICES

68890

Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices

HRSA specifically requests comments

on: (1) The necessity and utility of the

proposed information collection for the

proper performance of the agency’s

functions; (2) the accuracy of the

estimated burden; (3) ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4) the

use of automated collection techniques

or other forms of information

technology to minimize the information

collection burden.

Maria G. Button,

Director, Executive Secretariat.

[FR Doc. 2020–24122 Filed 10–29–20; 8:45 am]

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Ninth Meeting of the National Clinical

Care Commission

AGENCY

: Office on Women’s Health,

Office of the Assistant Secretary for

Health, Office of the Secretary,

Department of Health and Human

Services.

ACTION

: Notice.

SUMMARY

: The National Clinical Care

Commission (the Commission) will

conduct its ninth meeting virtually on

November 17, 2020. The Commission is

charged to evaluate and make

recommendations to the U.S.

Department of Health and Human

Services (HHS) Secretary and Congress

regarding improvements to the

coordination and leveraging of federal

programs related to diabetes and its

complications.

DATES

: The meeting will take place on

November 17, 2020, from 1 p.m. to

approximately 5:30 p.m. Eastern

Standard time (EST).

ADDRESSES

: The meeting will be held

online via webinar. To register to attend

the meeting, please visit the registration

website at https://

kauffmaninc.adobeconnect.com/nccc_

9/event/event_info.html.

FOR FURTHER INFORMATION CONTACT

:

Clydette Powell, M.D., M.P.H., F.A.A.P.,

Designated Federal Officer, National

Clinical Care Commission, U.S.

Department of Health and Human

Services, Office on Women’s Health,

200 Independence Ave. SW 7th Floor,

Washington DC 20201. Phone: (240)

453–8239. Email: OHQ@hhs.gov.

SUPPLEMENTARY INFORMATION

: The

National Clinical Care Commission Act

(Pub. L. 115–80) requires the HHS

Secretary to establish the National

Clinical Care Commission. The

Commission consists of representatives

of specific federal agencies and non-

federal individuals who represent

diverse disciplines and views. The

Commission will evaluate and make

recommendations to the HHS Secretary

and Congress regarding improvements

to the coordination and leveraging of

federal programs related to diabetes and

its complications.

The ninth meeting will be held

virtually and will consist of updates

from the Commission’s three

subcommittees and a discussion of

public comments and outreach to

stakeholder organizations. Additionally,

the Commission will discuss the second

round of potential ‘‘action plans’’ from

the subcommittees (i.e.,

recommendations). The final meeting

agenda will be available prior to the

meeting at https://health.gov/our-work/

health-care-quality/national-clinical-

care-commission/meetings.

Public Participation at Meeting: The

Commission invites public comment on

issues related to the Commission’s

charge. There will be an opportunity for

limited oral comments (each no more

than 3 minutes in length) at this virtual

meeting. Virtual attendees who plan to

provide oral comments at the

Commission meeting during a

designated time must register prior to

the meeting at https://

kauffmaninc.adobeconnect.com/nccc_

9/event/event_info.html.

Written comments are welcome

throughout the entire development

process of the Commission’s work and

may be emailed to OHQ@hhs.gov.

Written comments should not exceed

three pages in length.

Individuals who need special

assistance, such as sign language

interpretation or other reasonable

accommodations, should indicate the

special accommodation when

registering online or by notifying

Jennifer Gillissen at jennifer.gillissen@

kauffmaninc.com by November 9, 2020.

Authority: The National Clinical Care

Commission is required under the National

Clinical Care Commission Act (Pub. L. 115–

80). The Commission is governed by

provisions of the Federal Advisory

Committee Act (FACA), Public Law 92–463,

as amended (5 U.S.C., App.) which sets forth

standards for the formation and use of federal

advisory committees.

Dated: October 27, 2020.

Dorothy Fink,

Deputy Assistant Secretary for Women’s

Health, Office of the Assistant Secretary for

Health.

[FR Doc. 2020–24126 Filed 10–29–20; 8:45 am]

BILLING CODE 4150–32–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Allergy and

Infectious Diseases; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended, notice is hereby given of the

following meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The contract proposals and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the contract

proposals, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Allergy and Infectious Diseases Special

Emphasis Panel; Small Business Innovation

Research (SBIR) Phase II Program Contract

Solicitation (PHS 2019–1) Topic 74.

Date: November 24, 2020.

Time: 10:00 a.m. to 1:00 p.m.

Agenda: To review and evaluate contract

proposals.

Place: National Institute of Allergy and

Infectious Diseases, National Institutes of

Health, 5601 Fishers Lane, Room 3G62A,

Rockville, MD 20892, Bethesda, MD (Virtual

Meeting).

Contact Person: Eleazar Cohen, Ph.D.,

Scientific Review Officer, Scientific Review

Program, Division of Extramural Activities,

National Institute of Allergy and Infectious

Diseases, National Institutes of Health, 5601

Fishers Lane, Room 3G62A, Bethesda, MD

20892, (240) 669–5081, ecohen@

niaid.nih.gov.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.855, Allergy, Immunology,

and Transplantation Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health, HHS)

Dated: October 26, 2020.

Tyeshia M. Roberson,

Program Analyst, Office of Federal Advisory

Committee Policy.

[FR Doc. 2020–24081 Filed 10–29–20; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Final NIH Policy for Data Management

and Sharing and Supplemental

Information

AGENCY

: National Institutes of Health,

HHS.

VerDate Sep<11>2014 21:10 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

jbell on DSKJLSW7X2PROD with NOTICES