68802 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 

to pay the deductibles and coinsurance 

for dually-eligible beneficiaries. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This notice will not have a substantial 

effect on State or local governments. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 9, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: October 29, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–28251 Filed 11–4–10; 2:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children; Notice of Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children. 

Dates and Times: January 27, 2011, 8:30 

a.m. to 5 p.m. January 28, 2011, 8:30 a.m. to 

3:30 p.m. 

Place: Renaissance Washington, DC 

Dupont Circle Hotel, 1143 New Hampshire 

Avenue, NW., Washington, DC 20037. 

Status: The meeting will be open to the 

public with attendance limited to space 

availability. Participants are asked to register 

for the meeting by going to the registration 

Web site at http://altarum.cvent.com/event/ 

SACHDNC012011. The registration deadline 

is Tuesday, January 25, 2011. Individuals 

who need special assistance, such as sign 

language interpretation or other reasonable 

accommodations should indicate their needs 

on the registration Web site. The deadline for 

special accommodation requests is Friday, 

January 21, 2011. If there are technical 

problems gaining access to the Web site, 

please contact Maureen Ball, Meetings 

Coordinator at conferences@altarum.org. 

Purpose: The Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children (Advisory 

Committee) was established to advise and 

guide the Secretary regarding the most 

appropriate application of universal newborn 

screening tests, technologies, policies, 

guidelines and programs for effectively 

reducing morbidity and mortality in 

newborns and children having or at risk for 

heritable disorders. The Advisory Committee 

also provides advice and recommendations 

concerning the grants and projects authorized 

under the Public Health Service Act, 42 

U.S.C. 300b–10, (Heritable Disorders 

Program) as amended in the Newborn 

Screening Saves Lives Act of 2008. 

Agenda: The meeting will include: (1) 

Presentations from the following Advisory 

Committee workgroups: Communications, 

Health Information Technology, and 

Evidence Review; (2) a report from a National 

Survey of Recent and Prospective Mothers 

about Newborn Screening; and (3) 

presentations on the continued work and 

reports of the Advisory Committee’s 

subcommittees on laboratory standards and 

procedures, follow-up and treatment, and 

education and training. Proposed Agenda 

items are subject to change as priorities 

dictate. You can locate the Agenda, 

Committee Roster and Charter, presentations, 

and meeting materials at the home page of 

the Advisory Committee’s Web site at 

http://www.hrsa.gov/ 

heritabledisorderscommittee/. 

Public Comments: Members of the public 

can present oral comments during the public 

comment periods of the meeting, which are 

scheduled for both days of the meeting. 

Those individuals who want to make a 

comment are requested to register online by 

Tuesday, January 25, 2011, at http:// 

altarum.cvent.com/event/SACHDNC012011. 

Requests will contain the name, address, 

telephone number, and any professional or 

business affiliation of the person desiring to 

make an oral presentation. Groups having 

similar interests are requested to combine 

their comments and present them through a 

single representative. The list of public 

comment participants will be posted on the 

Web site. Written comments should be emailed via e-mail no later than Tuesday, 

January 25, 2011, for consideration. 

Comments should be submitted to Maureen 

Ball, Meetings Coordinator, Conference and 

Meetings Management, Altarum Institute, 

1200 18th Street, NW., Suite 700, 

Washington, DC 20036, telephone: 202 828– 

5100; fax: 202 785–3083, or e-mail: 

conferences@altarum.org. 

Contact Person: Anyone interested in 

obtaining other relevant information should 

write or contact Alaina M. Harris, Maternal 

and Child Health Bureau, Health Resources 

and Services Administration, Room 18A–19, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone (301) 

443–0721, aharris@hrsa.gov. More 

information on the Advisory Committee is 

available at http://mchb.hrsa.gov/ 

heritabledisorderscommittee. 

Dated: November 2, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–28188 Filed 11–8–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0369] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: Under the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act), the Food and 

Drug Administration (FDA) is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon by, holders 

of approved drug and biological 

products. This notice is the Agency’s 

report on the status of the studies and 

clinical trials that applicants have 

agreed to or are required to conduct. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn C. Lee, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6464, 

Silver Spring, MD 20993–0002, 301– 

796–0700; or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1400 

Rockville Pike, Rockville, MD 20852, 

301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Pub. L. 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by adding a new 

provision requiring reports of certain 

postmarketing studies, including 

clinical trials, for human drug and 

biological products (section 506B of the 

FD&C Act (21 U.S.C. 356b)). Section 

506B of the FD&C Act provides FDA 

with additional authority to monitor the 

progress of a postmarketing study or 

clinical trial that an applicant has been 

required to or has agreed to conduct by 

requiring the applicant to submit a 

report annually providing information 


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