9268 Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach, and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Lori 

J. Churchyard, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Investigating 

and Reporting Adverse Reactions 

Related to Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps) Regulated Solely Under 

Section 361 of the Public Health Service 

Act and 21 CFR part 1271’’ dated 

February 2015. The draft guidance 

document is intended provide 

manufacturers of HCT/Ps, with 

recommendations for complying with 

the requirements for investigating and 

reporting adverse reactions involving 

communicable disease in recipients of 

HCT/Ps that are regulated solely under 

section 361 of the Public Health Service 

Act (42 U.S.C. 264) and 21 CFR part 

1271 (361 HCT/Ps). 

The draft guidance, when finalized, is 

intended to supplement section XXII of 

FDA’s guidance entitled ‘‘Guidance for 

Industry: Current Good Tissue Practice 

(CGTP) and Additional Requirements 

for Manufacturers of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated December 

2011 by providing additional 

recommendations specific to the 

responsibilities to investigate 

complaints of adverse reactions 

concerning 361 HCT/Ps under 

§§ 1271.160(b)(2), 1271.320 and 

1271.350(a)(1). 

The draft guidance, when finalized, is 

intended to supersede the guidance 

entitled ‘‘Guidance for Industry: 

MedWatch Form FDA 3500A: 

Mandatory Reporting of Adverse 

Reactions Related to Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated November 

2005. The guidance will provide 

updated information specific to 

reporting adverse reactions related to 

HCT/Ps to supplement the general 

instructions accompanying the 

MedWatch mandatory reporting form, 

Form FDA 3500A. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 collections 

of information in part 1271 have been 

approved under OMB control number 

0910–0543 and OMB control number 

0910–0291. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: February 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03490 Filed 2–19–15; 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 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects (section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995), the 

Health Resources and Services 

Administration (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 Information 

Collection Request must be received no 

later than April 21, 2015. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail to the 

HRSA Information Collection Clearance 

Officer, Room 10–29, Parklawn 

Building, 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 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. 0915– 

xxxx—New. 

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 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Notices 9269 

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 

Compensation Act (RECA) claims. 

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 (GPRA) 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 medical user patient 

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 Energy 

Employees Occupational Illness 

Compensation Act programs; 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: (1) Review instructions; (2) 

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; (3) train 

personnel and to be able to respond to 

a collection of information; (4) search 

data sources; to complete and review 

the collection of information; and (5) 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this Information 

Collection Request are summarized in 

the table below. 

Total Estimated Annualized burden 

hours: 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

Radiation Exposure Screening and Education Program 

Performance Measures .................................................... 50 1 50 24 1,200 

Total .............................................................................. 50 1 50 24 1,200 

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. 

Jackie Painter, 

Director, Division of the Executive Secretariat. 

[FR Doc. 2015–03526 Filed 2–19–15; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Health 

Resources and Services Administration 

(HRSA) has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. 

DATES: Comments on this ICR should be 

received no later than March 23, 2015. 

ADDRESSES: Submit your comments, 

including the Information Collection 

Request Title, to the desk officer for 

HRSA, either by email to OIRA_

submission@omb.eop.gov or by fax to 

202–395–5806. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email the 

HRSA Information Collection Clearance 

Officer at paperwork@hrsa.gov or call 

(301) 443–1984. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

The Secretary’s Discretionary Advisory 

Committee on Heritable Disorders in 

Newborns and Children’s Public Health 

System Assessment Surveys OMB No. 

0906–xxxx—New. 

Abstract: The purpose of the public 

health system assessment surveys is to 

inform the Secretary’s Discretionary 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(Committee) on the ability to add 

newborn screening for particular 

conditions within a state, including the 

feasibility, readiness, and overall 

capacity to screen for a new condition. 

The Committee was established under 

the Public Health Service Act, 42 U.S.C. 

217a: Advisory Councils or Committees. 

This Committee fulfills the functions 

previously undertaken by the former 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children, established under section 

1111 of the Public Health Service Act 

(PHS), 42 U.S.C. 300b–10, as amended 

in the Newborn Screening Saves Lives 

Act of 2008. The Committee is governed 

by the provisions of the Federal 

Advisory Committee Act (FACA), as 

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

forth standards for the formation and 

use of advisory committees. The 

purpose of the Committee is to provide 

the Secretary with recommendations, 

advice, and technical information 

regarding the most appropriate 

application of technologies, policies, 


TKELLEY on DSK3SPTVN1PROD with NOTICES