41080 Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices 

There are no costs to respondents 

except their time to participate in the 

survey. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hrs.) 

Total burden 

(in hours) 

Grantees ........................................... Annual Application ........................... 61 1 25 1525 

Annual Report .................................. 61 1 30 1830 

Total ........................................... ........................................................... ........................ ........................ ........................ 3355 

Dated: July 20, 2007. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E7–14439 Filed 7–25–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee for Injury 

Prevention and Control (ACIPC), 

Science and Program Review 

Subcommittee 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces, the following meeting for 

the aforementioned committee and 

subcommittee: 

Name: Science and Program Review 

Subcommittee (SPRS). 

Times and Date: 11:30 a.m.–11:35 a.m., 

August 20, 2007 (Open). 11:35 a.m.–12:30 

p.m., August 20, 2007 (Closed). 

Place: CDC, Koger Center, Vanderbilt 

Building, Room 1006, 2939 Flowers Road, 

Atlanta, Georgia 30341–3724. 

Purpose: The subcommittee provides 

advice on the needs, structure, progress, and 

performance of programs in the National 

Center for Injury Prevention and Control 

(NCIPC). 

Matters To Be Discussed: The 

subcommittee will have a secondary review, 

discussion, and evaluation on the individual 

research grant and cooperative agreement 

applications submitted in response to the two 

Fiscal Year 2007 Requests for Applications 

(RFAs) related to the following individual 

research announcements: RFA–CE–05–020, 

Youth Violence Prevention through 

Community-Level Change; and RFA–CE–07–

011, Multi-Level Parent Training 

Effectiveness Trial—Phase II (U49). 

Following this meeting, the voting 

members of ACIPC will meet via 

teleconference to vote on the 

recommendations of the SPRS regarding the 

RFAs. 

Name: Advisory Committee for Injury 

Prevention and Control. 

Times and Date: 12:30 p.m.–12:55 p.m., 

August 20, 2007 (Open). 12:55 p.m.–1:30 

p.m., August 20, 2007 (Closed). 

Place: CDC, Koger Center, Vanderbilt 

Building, Room 1006, 2939 Flowers Road, 

Atlanta, Georgia 30341–3724. 

Purpose: The committee advises and makes 

recommendations to the Secretary, 

Department of Health and Human Services, 

the Director, CDC, and the Director, NCIPC 

regarding feasible goals for the prevention 

and control of injury. The committee makes 

recommendations regarding policies, 

strategies, objectives, and priorities, and 

reviews progress toward injury prevention 

and control. 

Matters To Be Discussed: Agenda items for 

the open portion include the call to order and 

introductions and request for public 

comments. The committee will vote on the 

results of the secondary review. This portion 

of the meeting will be closed to the public 

in accordance with the provisions set forth in 

section 552b(c)(4) and (b), title 5 U.S.C., and 

the Determination of the Acting Director, 

Management Analysis and Services Office, 

CDC pursuant to Public Law 92–463. 

Agenda items are subject to change as 

priorities dictate. 

For Further Information Contact: Ms. Amy 

Harris, Executive Secretary, ACIPC, NCIPC, 

CDC, 4770 Buford Highway, NE., M/S K61, 

Atlanta, Georgia 30341–3724, Telephone 

(770) 488–4936. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: July 17, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. E7–14430 Filed 7–25–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0290] 

Draft Guidance for Industry: Cell 

Selection Devices for Point of Care 

Production of Minimally Manipulated 

Autologous Peripheral Blood Stem 

Cells; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Cell Selection 

Devices for Point of Care Production of 

Minimally Manipulated Autologous 

Peripheral Blood Stem Cells (PBSCs)’’

dated July 2007. The draft guidance 

document discusses certain cell 

selection devices that minimally 

manipulate autologous PBSCs at the 

point of care for specific clinical 

indications, and the applicability of the 

requirements to such PBSCs. The 

guidance also discusses the submission 

of data intended to support approval of 

cell selection devices. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance submit 

written or electronic comments on the 

draft guidance by October 24, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

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–


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 143 / Thursday, July 26, 2007 / Notices 41081 

800–835–4709 or 301–827–1800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Cell Selection Devices for 

Point of Care Production of Minimally 

Manipulated Autologous Peripheral 

Blood Stem Cells (PBSCs)’’ dated July 

2007. The draft guidance document 

discusses certain cell selection devices 

that minimally manipulate autologous 

PBSCs at the point of care for specific 

clinical indications, and the 

applicability of the requirements of 21 

CFR part 1271 to such PBSCs. The 

guidance also discusses the submission 

of data intended to support approval of 

cell selection devices. 

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 

This 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 21 CFR part 812 have 

been approved under 0910–0078; the 

collections of information in 21 CFR 

part 814 have been approved under 

0910–0231; the collections of 

information in 21 CFR part 820 have 

been approved under 0910–0073; and 

the collections of information in 21 CFR 

part 822 have been approved under 

0910–0449. 

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 to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: July 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–3659 Filed 7–23–07; 12:02 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0347] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; In Vitro 

Diagnostic Multivariate Index Assays; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

entitled ‘‘In Vitro Diagnostic 

Multivariate Index Assays.’’ FDA is 

issuing this revised draft guidance to 

address the definition and regulatory 

status of a class of In Vitro Diagnostic 

Devices referred to as In Vitro 

Diagnostic Multivariate Index Assays 

(IVDMIAs). The revised draft guidance 

also addresses premarket and 

postmarket requirements with respect to 

IVDMIAs. The initial draft of this 

guidance was issued September 7, 2006. 

DATES: Submit written or electronic 

comments on this draft guidance by 

August 27, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘In Vitro Diagnostic 

Multivariate Index Assays’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850 or to the Office of 

Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 240–276–

3151. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the draft guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Courtney Harper, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0694. 

For further information concerning 

the guidance as it related to devices 

regulated by CBER: Martin Ruta, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–3518. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

7, 2006 (71 FR 52800). FDA published 

a notice of availability of the initial draft 

guidance to address the definition and 

regulatory status of a class of in vitro 

diagnostic devices referred to as ‘‘In 

Vitro Diagnostic Multivariate Index 

Assays (IVDMIAs).’’ The initial draft 

guidance also addressed premarket and 

postmarket requirements with respect to 

IVDMIAs. 

An IVDMIA, as defined in the draft 

guidance document, is a device within 

the meaning of the Federal Food, Drug, 

and Cosmetic Act (the act). Some 

IVDMIAs are laboratory-developed tests 

(LDTs); laboratory-developed IVDMIAs 

are a specific subset of LDTs. While 

FDA has stated that ‘‘clinical 

laboratories that develop (in-house) tests 


rwilkins on PROD1PC63 with NOTICES