Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 65495 

national and State statistics on public 

and private residential services for 

individuals with intellectual and 

developmental disabilities, including 

disaggregation of data related to specific 

demographic groups. The project will 

conduct analyses that describe the 

movement of individuals with 

intellectual and developmental 

disabilities from institutional to 

community settings. Project staff will 

also participate in collaborative efforts 

with ADD and other data collection 

projects to review and report on unmet 

needs in data collection, analyses, and 

reporting activities that would promote 

the self-determination, independence, 

productivity, and integration and 

inclusion of people with intellectual 

and developmental disabilities in all 

facets of community life. 

Contact for Further Information: 

Ophelia McLain, Supervisory Program 

Specialist, Administration on 

Developmental Disabilities, 370 

L’Enfant Promenade, SW., Mail Stop: 

HHH–405D, Washington, DC 20447. 

Telephone: 202–690–7025 E-mail: 

ophelia.mclain@acf.hhs.gov. 

Dated: October 14, 2010. 

Sharon Lewis, 

Commissioner, Administration on 

Developmental Disabilities. 

[FR Doc. 2010–26933 Filed 10–22–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental and 

Craniofacial Research; Interagency 

Pain Research Coordinating 

Committee; Call for Nominations 

The Department of Health and Human 

Services has created the Interagency 

Pain Research Coordinating Committee 

and is seeking nominations for this 

committee. As specified in Public Law 

111–148 (‘‘Patient Protection and 

Affordable Care Act’’) the Committee 

will: (a) Develop a summary of advances 

in pain care research supported or 

conducted by the Federal agencies 

relevant to the diagnosis, prevention, 

and treatment of pain and diseases and 

disorders associated with pain; (b) 

identify critical gaps in basic and 

clinical research on the symptoms and 

causes of pain; (c) make 

recommendations to ensure that the 

activities of the National Institutes of 

Health and other Federal agencies are 

free of unnecessary duplication of effort; 

(d) make recommendations on how best 

to disseminate information on pain care; 

and (e) make recommendations on how 

to expand partnerships between public 

entities and private entities to expand 

collaborative, cross-cutting research. 

Membership on the committee will 

include six (6) non-Federal members 

from among scientists, physicians, and 

other health professionals and six (6) 

non-Federal members of the general 

public who are representatives of 

leading research, advocacy, and service 

organizations for individuals with painrelated conditions. Members will serve 

overlapping three year terms. It is 

anticipated that the committee will meet 

at least once a year. 

The Department strives to ensure that 

the membership of HHS Federal 

advisory committees is fairly balanced 

in terms of points of view represented 

and the committee’s function. Every 

effort is made to ensure that the views 

of women, all ethnic and racial groups, 

and people with disabilities are 

represented on HHS Federal advisory 

committees and, therefore, the 

Department encourages nominations of 

qualified candidates from these groups. 

The Department also encourages 

geographic diversity in the composition 

of the Committee. Appointment to this 

Committee shall be made without 

discrimination on the basis of age, race, 

ethnicity, gender, sexual orientation, 

disability, and cultural, religious, or 

socioeconomic status. 

Nominations are due by COB 

November 26, 2010, and should be sent 

to Amy Adams, PhD, NIDCR/NIH, 31 

Center Drive, Room 5B55, MSC–2190, 

Bethesda MD 20892–2190, 

adamsamy@mail.nih.gov by either 

USPS mail or e-mail. Nominations 

should include contact information and 

a current curriculum vitae or resume. 

Dated: October 18, 2010. 

Amy Adams, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health. 

[FR Doc. 2010–26937 Filed 10–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0529] 

Draft Guidance for Industry on 

Qualification Process for Drug 

Development Tools; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Qualification Process 

for Drug Development Tools.’’ This draft 

guidance describes the qualification 

process for drug development tools 

(DDTs) intended for potential use, over 

time, in multiple drug development 

programs. The draft guidance provides a 

framework for interactions between the 

Center for Drug Evaluation and Research 

(CDER) and DDT sponsors to support 

work towards qualification of an 

identified DDT and creates a mechanism 

for formal review of data by CDER to 

qualify the DDT and ensure that the 

evaluation is comprehensive and 

reliable. 

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 

either electronic or written comments 

on the draft guidance by January 24, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. 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: 

Shaniece Gathers, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 4555, 

Silver Spring, MD 20993–0002, 301– 

796–2600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Qualification Process for Drug 

Development Tools.’’ In March 2006, 

FDA issued the ‘‘Critical Path 

Opportunities Report’’ and the ‘‘Critical 

Path Opportunities List.’’ In these 

reports, FDA described six key areas 

along the critical path to improved 

therapies, and a list of specific 

opportunities for advancement within 

these topic areas. The opportunities 

report noted that a new product 


emcdonald on DSK2BSOYB1PROD with NOTICES
65496 Federal Register / Vol. 75, No. 205 / Monday, October 25, 2010 / Notices 

development toolkit containing new 

scientific and technical methods was 

needed to improve the efficiency of drug 

development. Too often, attention to a 

needed DDT is delayed until the time 

when the registration study protocols 

are under development and the 

available DDTs are inadequate. 

Innovative and improved DDTs are 

among the methods that can help 

streamline the drug development 

process, improve the chances for 

clinical trial success, and yield more 

information about the treatment and/or 

disease. DDTs include, but are not 

limited to biomarkers and patient 

reported outcome instruments. This 

draft guidance describes a formal 

process that CDER will use in working 

with sponsors of these tools to guide 

them as they refine the tools and 

rigorously evaluate them for use in the 

regulatory process. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on the qualification process for DDTs . 

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 

requirements of the applicable statutes 

and regulations. 

II. The 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 312.30, 21 CFR 

314.50(d)(5), and 21 CFR 314.126(b)(6) 

have been approved under OMB control 

numbers 0910–0001 and 0910–0014. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: October 19, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26927 Filed 10–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Kochanek T32. 

Date: November 16, 2010. 

Time: 1:30 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Peter Zelazowski, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child, Health and 

Human Development, NIH, 6100 Executive 

Boulevard, Room 5B01, Bethesda, MD 

20892–7510, 301–435–6902, 

peter.zelazowski@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 19, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26874 Filed 10–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; Cornelia de Lange 

Syndrome. 

Date: November 15, 2010. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Neelakanta Ravindranath, 

PhD, Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Blvd., Room 5B01G, Bethesda, MD 20892, 

301–435–6889, ravindrn@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 19, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26875 Filed 10–22–10; 8:45 am] 

BILLING CODE 4140–01–P 


emcdonald on DSK2BSOYB1PROD with NOTICES