Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 50213 

Methods (SACATM), ICCVAM 

unanimously endorsed the nomination 

with a high priority. ICCVAM and 

NICEATM began evaluation activities 

and also initiated development of 

proposed test method performance 

standards for the LLNA since these had 

not previously been developed (http:// 

iccvam.niehs.nih.gov/methods/ 

immunotox/immunotox.htm). 

NICEATM and ICCVAM compiled a 

comprehensive draft BRD on the rLLNA 

test method and a draft test method 

performance standards document for the 

LLNA and released them for public 

comment in January 2008 (73 FR 1360). 

NICEATM and ICCVAM convened the 

Panel at a meeting on March 4–6, 2008, 

to review the draft BRDs and evaluate 

the validation status of the proposed test 

methods and applications. The Panel 

also reviewed the extent that the 

information contained in the draft BRDs 

supported draft ICCVAM test method 

recommendations for test method uses 

and limitations, updated standardized 

test method protocols, and proposed 

future studies. The Panel reviewed the 

draft ICCVAM LLNA test method 

performance standards for their 

adequacy for assessing the accuracy and 

reliability of test method protocols that 

are based on similar scientific principles 

and that measure the same biological 

effect as the traditional LLNA. The 

Panel considered public comments 

made at the meeting as well as public 

comments submitted in advance of the 

meeting, before concluding their 

deliberations. The Panel’s report was 

made available in May 2008 (73 FR 

29136) for public comment. The draft 

ICCVAM BRDs, draft ICCVAM test 

method recommendations, draft 

ICCVAM LLNA test method 

performance standards, the Panel’s 

report, and all public comments were 

made available to the SACATM for 

comment on June 18–19, 2008 (73 FR 

25754). 

ICCVAM considered the Panel’s 

report, all public comments, and 

SACATM comments in finalizing its 

recommendations for the rLLNA, the 

updated LLNA test method protocol, 

and LLNA test method performance 

standards. ICCVAM has forwarded its 

test method recommendations to U.S. 

Federal agencies for consideration, in 

accordance with the ICCVAM 

Authorization Act of 2000 (42 U.S.C. 

285l–3(e)(4)). Agency responses to the 

ICCVAM test method recommendations 

will be made available on the 

NICEATM–ICCVAM Web site as they 

are received. 

Background Information on ICCVAM, 

NICEATM, and SACATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that use, generate, or disseminate 

toxicological information. ICCVAM 

conducts technical evaluations of new, 

revised, and alternative methods with 

regulatory applicability and promotes 

the scientific validation and regulatory 

acceptance of toxicological test methods 

that more accurately assess the safety 

and hazards of chemicals and products 

and that refine, reduce, and replace 

animal use. The ICCVAM Authorization 

Act of 2000 established ICCVAM as a 

permanent interagency committee of the 

NIEHS under NICEATM. NICEATM 

administers ICCVAM and provides 

scientific and operational support for 

ICCVAM-related activities. NICEATM 

and ICCVAM work collaboratively to 

evaluate new and improved test 

methods applicable to the needs of U.S. 

Federal agencies. Additional 

information about ICCVAM and 

NICEATM can be found on their Web 

site (http://www.iccvam.niehs.nih.gov). 

SACATM was established January 9, 

2002, and is composed of scientists from 

the public and private sectors (67 FR 

11358). SACATM provides advice to the 

Director of the NIEHS, ICCVAM, and 

NICEATM regarding the statutorilymandated duties of ICCVAM and 

activities of NICEATM. Additional 

information about SACATM, including 

the charter, roster, and records of past 

meetings, can be found at http:// 

ntp.niehs.nih.gov/go/167. 

Dated: September 22, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–23534 Filed 9–29–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Renewal of Charter for the Secretary’s 

Advisory Committee on National 

Health Promotion and Disease 

Prevention Objectives for 2020 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science, 

Office of Disease Prevention and Health 

Promotion. 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, as amended (5 

U.S.C. Appendix 2), the U.S. 

Department of Health and Human 

Services is hereby announcing that the 

charter for the Secretary’s Advisory 

Committee on National Health 

Promotion and Disease Prevention 

Objectives for 2020 (Healthy People 

2020 Advisory Committee; HPAC) has 

been renewed. 

FOR FURTHER INFORMATION CONTACT: 

Emmeline Ochiai, Executive Secretary, 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2020, 

Department of Health and Human 

Services, Office of Public Health and 

Science, Office of Disease Prevention 

and Health Promotion, 1101 Wootton 

Parkway, Room LL–100, Rockville, MD 

20852; Telephone: (240) 453–8259; Fax 

(240) 453–8281. Additional information 

is available on the Internet at http:// 

www.healthypeople.gov. 

SUPPLEMENTARY INFORMATION: Every ten 

years, through the Healthy People 

initiative, the U.S. Department of Health 

and Human Services (HHS) leverages 

scientific insights and lessons from the 

past decade, along with the new 

knowledge of current data, trends, and 

innovations to develop the next 

iteration of the national health 

promotion and disease prevention 

objectives. Healthy People provides 

science-based, ten-year national 

objectives for promoting health and 

preventing disease. Since 1980, Healthy 

People has set and monitored national 

health objectives to meet a broad range 

of health needs, encourage 

collaborations across sectors, guide 

individuals toward making informed 

health decisions, and measure the 

impact of our prevention and health 

promotion activities. Healthy People 

2020 will reflect assessment of major 

risks to health and wellness, changing 

public health priorities, and emerging 

technologies related to our nation’s 

health preparedness and prevention. 

The Committee will continue to 

provide advice and consultation to the 

Secretary of Health and Human Services 

for developing and implementing the 

next iteration of the national health 

promotion and disease prevention goals 

and objectives and provide 

recommendations for initiatives to occur 

during the implementation phase of the 

goals and objectives. HHS will use the 

recommendations to form the 

development of the national health 

promotion and disease prevention 

objectives for 2020 and the process for 

implementing the objectives. The intent 

is to develop and launch objectives 

designed to improve the health status 

and reduce health risks for Americans 

by the year 2020. Renewal of the HPAC 

charter provides authorization for the 

Committee to operate until September 4, 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
50214 Federal Register / Vol. 74, No. 188 / Wednesday, September 30, 2009 / Notices 

2011. A copy of the Committee charter 

can be obtained by contacting the 

Committee’s Executive Secretary. A 

copy of the Committee charter also can 

be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The Web site address 

for the FACA database is http://fido.gov/ 

facadatabase. 

Dated: September 23, 2009. 

Penelope Slade-Sawyer, 

RADM, USPHS, Deputy Assistant Secretary 

for Health (Disease Prevention and Health 

Promotion), Office of Disease Prevention and 

Health Promotion. 

[FR Doc. E9–23539 Filed 9–29–09; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0434] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Humanitarian Device Exemption 

Holders, Institutional Review Boards, 

Clinical Investigators, and Food and 

Drug Administration Staff: 

Humanitarian Device Exemption 

Regulation: Questions and Answers; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by October 30, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title Guidance for Humanitarian Device 

Exemption Holders, Institutional 

Review Boards, Clinical Investigators, 

and FDA Staff: Humanitarian Device 

Exemption Regulation: Questions and 

Answers; Availability. Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Humanitarian Device 

Exemption Holders, Institutional 

Review Boards, Clinical Investigators, 

and FDA Staff: Humanitarian Device 

Exemption Regulation: Questions and 

Answers—(OMB Control Number 0910– 

NEW) 

Title III of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) (Public Law 110–85) 

amended chapter V of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 351 et seq.) by inserting section 

515A, Pediatric Uses of Devices (21 

U.S.C. 360e–1). 

This new provision requires that new 

applications under section 520(m) of the 

act (21 U.S.C. 360j(m)) include both a 

description of any pediatric 

subpopulation that suffer from: (1) A 

disease or condition that the device is 

intended to treat, diagnose, or cure and 

(2) the number of affected pediatric 

patients. 

Title III of FDAAA also amended 

section 520(m) of the act as follows: 

Section 520(m)(6)(A)(ii) of the act 

provides that the Secretary of Health 

and Human Services will assign an 

annual distribution number (ADN) for 

devices indicated for use in a pediatric 

population or in a pediatric 

subpopulation. The ADN shall be based 

on the following information in a 

humanitarian device exemption (HDE) 

application: (1) The number of 

individuals affected by the disease or 

condition that such device is intended 

to treat, diagnose, or cure and of that 

number; (2) the number of individuals 

likely to use the device and (3) the 

number of devices reasonably necessary 

to to treat such individuals. 

Section 520(m)(6)(A)(iii) of the act 

provides that an HDE holder 

immediately notify the agency if the 

number of devices distributed during 

any calendar year exceeds the ADN. 

Section 520(m)(6)(C) of the act 

provides that an HDE holder may 

petition to modify the ADN if additional 

information on the number of 

individuals affected by the disease or 

condition arises. 

In the Federal Register of August 5, 

2008 (73 FR 45460), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. Seven comments were 

received in response to the 60-day 

notice. Of the seven comments received, 

six related to the guidance and the 

information collection requests. We 

received one comment that did not 

address the content of the guidance nor 

the information collection. 

There were a number of comments 

received that clarified the reporting 

requirements for HDE holders and 

institutional review boards (IRBs). In 

response to these comments, FDA 

responded by referring to previously 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

803.50 have been approved under OMB 

control number 0910–0437 and the 

collections of information in part 814 

(21 CFR part 814) have been approved 

under OMB control number 0910–0332. 

FDA received comments that sought 

clarification regarding how an IRB 

distinguishes between the use of a 

humanitarian use device (HUD) and the 

study of an HUD in a clinical 

investigation. FDA responded by 

providing additional background 

information related to the collection of 

safety and effectiveness information 

related to clinical investigation for HDE 

approved indications and referring to 

previously approved collections of 

information found in FDA regulations. 

This collection of information is 

approved under OMB control number 

0910–0078. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Federal Food, Drug, 

and Cosmetic Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

515A(a)(2) 5 1 5 100 500 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES