Federal Register / Vol. 76, No. 4 / Thursday, January 6, 2011 / Notices 789 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Planning, Research and 

Evaluation Advisory Committee on 

Head Start Research and Evaluation 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces a 

forthcoming meeting of a public 

advisory committee of the 

Administration for Children and 

Families (ACF). The meeting will be 

open to the public. 

Name of Committee: Advisory 

Committee for Head Start Research and 

Evaluation. 

General Function of Committee: The 

Advisory Committee for Head Start 

Research and Evaluation will provide 

feedback on the published final report 

for the Head Start Impact Study, offering 

interpretations of the findings, 

discussing implications for practice and 

policy, and providing recommendations 

on follow-up research, including 

additional analysis of the Head Start 

Impact Study data. The Committee will 

also be asked to provide 

recommendations to the Secretary 

regarding how to improve Head Start 

and other early childhood programs by 

enhancing the use of research-informed 

practices in early childhood. Finally, 

the Committee will be asked to provide 

recommendations on the overall Head 

Start research agenda, including—but 

not limited to—how the Head Start 

Impact Study fits within this agenda. 

The Committee will provide advice 

regarding future research efforts to 

inform HHS about how to guide the 

development and implementation of 

best practices in Head Start and other 

early childhood programs around the 

country. 

DATES: The meeting will be held from 

8:30 a.m. to 5 p.m. on January 25, 2011, 

and from 8:30 a.m. to 4 p.m. on January 

26, 2011. 

ADDRESSES: Four Points by Sheraton 

Hotel, 1201 K Street, NW., Washington, 

DC 20005, (202) 289–7600. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Brooks, Office of Planning, 

Research, and Evaluation, e-mail 

jennifer.brooks@acf.hhs.gov or call (202) 

205–8212. 

Agenda: The Committee will review 

information on the federal Head Start 

program and the children and families 

it serves, review the design and findings 

of the Head Start Impact Study, and 

review plans for future research on the 

impact of Head Start. To inform its 

deliberations, the Committee will also 

review the evidence related to Early 

Head Start and programs supporting 

children from birth through age 5, as 

well as evidence related to elementary 

school quality and how best to sustain 

benefits from early childhood programs 

through the early elementary school 

years. 

Procedure: Interested persons may 

present data, information or views, in 

writing, on issues pending before the 

Committee. Written submissions may be 

made to the contact person on or before 

January 15, 2011. All written materials 

provided to the contact person will be 

shared with the Committee members. 

ACF welcomes the attendance of the 

public at this advisory committee 

meeting and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Jennifer 

Brooks at least seven days in advance of 

the meeting. Notice of this meeting is 

given under the Federal Advisory 

Committee Act (5 U.S.C. app. 2). 

Dated: December 22, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–33242 Filed 1–5–11; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0635] 

Guidance for Industry and Food and 

Drug Administration Staff; Section 

905(j) Reports: Demonstrating 

Substantial Equivalence for Tobacco 

Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

and FDA staff entitled ‘‘Section 905(j) 

Reports: Demonstrating Substantial 

Equivalence for Tobacco Products.’’ In 

general, the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) requires a 

premarket application and market 

authorization order for new tobacco 

products before they may be marketed; 

alternatively, manufacturers may submit 

a 905(j) report intended to demonstrate 

substantial equivalence to a predicate 

tobacco product. The guidance provides 

recommendations on submitting 

information intended to demonstrate 

that a new tobacco product is 

substantially equivalent to a predicate 

tobacco product. Manufacturers of 

tobacco products first introduced or 

delivered for introduction into interstate 

commerce for commercial distribution 

after February 15, 2007, and prior to 

March 22, 2011, must submit a report no 

later than March 22, 2011, or the 

products can no longer be legally 

marketed. Manufacturers of a new 

tobacco product first introduced or 

delivered for introduction into interstate 

commerce for commercial distribution 

after February 15, 2007 and before 

March 22, 2011, who submit a 

substantial equivalence report before 

March 23, 2011, may continue to market 

the tobacco product unless FDA issues 

an order finding that the product is not 

substantially equivalent. Because it is 

important that FDA’s recommendations 

on submitting a substantial equivalence 

reports be available to assist new 

tobacco product manufacturers in 

preparing substantial equivalence 

reports in advance of March 23, 2011, 

this guidance document will be 

implemented immediately. This 

guidance, however, remains subject to 

comment in accordance with the 

Agency’s good guidance practices 

(GGPs). 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit electronic 

comments on the guidance, including 

comments regarding the proposed 

collection of information, to http:// 

www.regulations.gov. Submit written 

comments on the guidance, including 

comments regarding the proposed 

collection of information, to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

Submit written requests for single 

copies of the guidance document 

entitled ‘‘Section 905(j) Reports: 

Demonstrating Substantial Equivalence 

for Tobacco Products’’ to the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 


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