Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48865 

vaccines; (3) advises the Director of the 

NVP in the implementation of Sections 

2102 and 2103 of the PHS Act; and (4) 

identifies annually for the Director of 

the NVP the most important areas of 

governmental and non-governmental 

cooperation that should be considered 

in implementing Sections 2101 and 

2103 of the PHS Act. 

NVAC was established on July 30, 

1987. As a Federal advisory committee, 

NVAC is governed by the provisions of 

the Federal Advisory Committee Act, 

Public Law 92–463, as amended (5 

U.S.C. App.) To comply with the 

guidelines under FACA, NVAC has been 

re-chartered at the appropriate intervals 

since it was established. On July 27, 

2011, the Assistant Secretary for Health 

approved for NVAC to be rechartered. 

The new charter was effected and filed 

with the appropriate Congressional 

offices and Library of Congress on July 

30, 2011. The rechartering of NVAC 

gives authorization for the Committee to 

continue to operate until July 30, 2013. 

A copy of the NVAC charter is 

available on the website for the National 

Vaccine Program Office at http:// 

www.hhs.gov/nvpo/nvac. A copy of the 

charter also can be obtained by 

accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

website address for the FACA database 

is http://fido.gov/facadatabase. 

Bruce Gellin, 

Deputy Assistant Secretary for Health 

(Vaccines and Immunization), Director, 

National Vaccine Program Office. 

[FR Doc. 2011–20197 Filed 8–8–11; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: The OCSE–157 Child Support 

Enforcement Annual Data Report. 

OMB No.: 0970–0177. 

Description: The information obtained 

from this form will be used to: (1) 

Report Child Support Enforcement 

activities to the Congress as required by 

law; (2) calculate incentive measures 

performance and performance 

indicators utilized in the program; and 

(3) assist the Office of Child Support 

Enforcement (OCSE) in monitoring and 

evaluating State Child Support 

programs. OCSE is proposing minor 

changes to the OCSE–157 report 

instructions for medical support line 

items that will provide states with the 

option to define medical support to 

include private health insurance as well 

as other health care coverage such as 

Medicaid, Children’s Health Insurance 

Program (CHIP) and other state coverage 

plans, and cash medical support. 

Further legislative or regulatory changes 

may be necessary to update medical 

child support policy. 

Respondents: State, Local or Tribal 

Government. 

Annual Burden Estimates. 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

OCSE–157 Child Support Annual Data Report ............................................... 54 1 7 378 

Estimated Total Annual Burden 

Hours: 378. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis 

Reports Clearance Officer. 

[FR Doc. 2011–20105 Filed 8–8–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meetings 

AGENCY: Administration for Children 

and Families’ Office of Head Start 

(OHS). 

ACTION: Notice of meetings. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, Public Law 110–134, notice is 

hereby given of one-day Tribal 

Consultation Sessions to be held 

between the Department of Health and 

Human Services, Administration for 

Children and Families, Office of Head 

Start leadership and the leadership of 

Tribal Governments operating Head 

Start (including Early Head Start) 

programs. The purpose of these 

Consultation Sessions is to discuss ways 

to better meet the needs of American 

Indian and Alaska Native children and 

their families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations [42 U.S.C. 9835, 

Section 640(l)(4)]. 

DATES: October 17 and 19, 2011. 

ADDRESSES: 2011 Office of Head Start 

Tribal Consultation Sessions will be 

held at the following locations: Monday, 

October 17, 2011— Seattle, 

Washington—Westin Seattle,1900 5th 

Avenue, Seattle, WA 98101; 

Wednesday, October 19, 2011— 

Anchorage, Alaska—Sheraton 

Anchorage Hotel & Spa, 401 East 6th 

Avenue, Anchorage, AK 99501. 

FOR FURTHER INFORMATION CONTACT: 

Camille Loya, Acting Regional Program 

Manager Region XI, e-mail 

Camille.Loya@acf.hhs.gov or phone 

(202) 401–5964. Additional information 

and online meeting registration is 

available at http:// 

www.headstartresourcecenter.org. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces Office of 

Head Start (OHS) Tribal Consultations 


sroberts on DSK5SPTVN1PROD with NOTICES
48866 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

for leaders of Tribal Governments 

operating Head Start and Early Head 

Start programs in Region X and in 

Alaska. The Consultation Session for 

Region X will take place Monday, 

October 17, 2011, in Seattle, 

Washington. The Consultation Session 

for the State of Alaska will take place 

Wednesday, October 19, 2011, in 

Anchorage, Alaska, immediately 

preceding the annual Alaska Federation 

of Natives convention. We are 

convening the OHS Tribal Consultations 

in conjunction with other Tribal Leader 

events in order to minimize the 

financial and travel burden for 

participants. 

The agendas for both scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of American Indian 

and Alaska Native children and 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2010 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for the Seattle or 

Anchorage Consultation Sessions 

should contact Camille Loya at 

Camille.Loya@acf.hhs.gov at least three 

days in advance of the Session. 

Proposals should include a brief 

description of the topic area along with 

the name and contact information of the 

suggested presenter. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 

U.S.C.9835, Section 640(l)(4)(A)]. 

Designees must have a letter from the 

Tribal Government authorizing them to 

represent the Tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Camille 

Loya at (202) 205–9721 (fax). Other 

representatives of Tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Camille Loya at 

Camille.Loya@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in the report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for all 

Consultation Sessions has been sent to 

Tribal leaders via e-mail and posted on 

the Head Start Resource Center Web site 

at http:// 

www.headstartresourcecenter.org. 

Dated: August 1, 2011. 

Yvette Sanchez Fuentes, 

Director, Office of Head Start. 

[FR Doc. 2011–20071 Filed 8–8–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0116] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Labeling Regulations 

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 September 

8, 2011. 

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: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0485. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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. 

Medical Device Labeling Regulations— 

(OMB Control Number 0910–0485)— 

(Extension) 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded and subject to a 

regulatory action. Certain provisions 

under section 502 require 

manufacturers, importers, and 

distributors of medical devices to 

disclose information about themselves 

or the devices, on the labels or labeling 

for the devices. 

Section 502(b) of the FD&C Act 

requires that for packaged devices, the 

label must bear the name and place of 

business of the manufacturer, packer, or 

distributor as well as an accurate 

statement of the quantity of the 

contents. Section 502(f) of the FD&C Act 

requires that the labeling for a device 

must contain adequate directions for 

use. FDA may however, grant an 

exemption, if the Agency determines 

that the adequate directions for use 

labeling requirements are not necessary 

for the particular case, as it relates to 

protection of the public health. 

FDA regulations under parts 800, 801, 

and 809 (21 CFR parts 800, 801, and 

809) require disclosure of specific 

information by manufacturers, 

importers, and distributors of medical 

devices about themselves or the devices, 

on the label or labeling for the devices 

to health professionals and consumers. 

FDA issued these regulations under the 

authority of sections 201, 301, 502, and 

701 of the FD&C Act (21 U.S.C. 321, 

331, 352, and 371). Most of the 

regulations under parts 800, 801, and 

809 are derived from requirements of 

section 502 of the FD&C Act, which 

provides in part, that a device shall be 

misbranded if among other things, its 

label or labeling fails to bear certain 

required information concerning the 

device, is false or misleading in any 

particular way, or fails to contain 

adequate directions for use. 

Reporting Burden 

Sections 800.10(a)(3) and 800.12(c) 

require that the label for contact lens 

cleaning solutions bear a prominent 

statement alerting consumers of the 

tamper-resistant feature. Further, 

§ 800.12 requires that packaged contact 

lens cleaning solutions contain a 

tamper-resistant feature, to prevent 

malicious adulteration. 


sroberts on DSK5SPTVN1PROD with NOTICES