17482 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 

FOR FURTHER INFORMATION CONTACT: Ms. 

Dana Munson, Procurement Analyst, 

General Services Acquisition Policy 

Division, GSA, at telephone (202) 357– 

9652 or via email to 

dana.munson@gsa.gov. 

ADDRESSES: Submit comments 

identified by Information Collection 

3090–0262, Identification of Products 

with Environmental Attributes, by any 

of the following methods: 

• Regulations.gov: http:// 

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

inputting ‘‘Information Collection 3090– 

0262, Identification of Products with 

Environmental Attributes’’, under the 

heading ‘‘Enter Keyword or ID’’ and 

selecting ‘‘Search’’. Select the link 

‘‘Submit a Comment’’ that corresponds 

with ‘‘Information Collection 3090– 

0262, Identification of Products with 

Environmental Attributes’’. Follow the 

instructions provided at the ‘‘Submit a 

Comment’’ screen. Please include your 

name, company name (if any), and 

‘‘Information Collection 3090–0262, 

Identification of Products with 

Environmental Attributes’’ on your 

attached document. 

• Fax: 202–501–4067. 

• Mail: General Services 

Administration, Regulatory Secretariat 

(MVCB), 1275 First Street NE., 

Washington, DC 20417. Attn: Hada 

Flowers/IC 3090–0262, Identification of 

Products with Environmental 

Attributes. 

Instructions: Please submit comments 

only and cite Information Collection 

3090–0262, Identification of Products 

with Environmental Attributes, in all 

correspondence related to this 

collection. All comments received will 

be posted without change to http:// 

www.regulations.gov, including any 

personal and/or business confidential 

information provided. 

SUPPLEMENTARY INFORMATION: 

A. Purpose 

General Services Administration 

(GSA) requires contractors submitting 

Multiple Award Schedule Contracts to 

identify in their GSA price lists those 

products that they market commercially 

that have environmental attributes. The 

identification of these products will 

enable Federal agencies to maximize the 

use of these products to meet the 

responsibilities expressed in statutes 

and executive orders. 

B. Annual Reporting Burden 

Respondents: 9,000. 

Responses per Respondent: 1. 

Annual Responses: 9,000. 

Hours per Response: 3. 

Total Burden Hours: 27,000. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the Regulatory Secretariat Division 

(MVCB), 1275 First Street NE., 

Washington, DC 20417, telephone (202) 

501–4755. Please cite OMB Control No. 

3090–0262, Identification of Products 

with Environmental Attributes, in all 

correspondence. 

Dated: March 19, 2012. 

Joseph A. Neurauter, 

Director, Office of Acquisition Policy, Senior 

Procurement Executive. 

[FR Doc. 2012–7197 Filed 3–23–12; 8:45 am] 

BILLING CODE 6820–61–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Agency Information Collection 

Activities; Submission for OMB 

Review; Comment Request; State 

Annual Long-Term Care Ombudsman 

Report and Instructions 

AGENCY: Administration on Aging, HHS. 

ACTION: Notice. 

SUMMARY: The Administration on Aging 

(AoA) is announcing that the proposed 

collection of information listed below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review and clearance under the 

Paperwork Reduction Act of 1995. 

DATES: Submit written comments on the 

collection of information by April 25, 

2012. 

ADDRESSES: Submit written comments 

on the collection of information by fax 

202.395.6974 or by mail to the Office of 

Information and Regulatory Affairs, 

OMB, New Executive Office Bldg., 725 

17th St. NW., Rm. 10235, Washington, 

DC 20503, Attn: Brenda Aguilar, Desk 

Officer for AoA. 

FOR FURTHER INFORMATION CONTACT: 

Louise Ryan, telephone: (202) 357–3503; 

email: louise.ryan@aoa.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, AoA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

States provide the following data and 

narrative information in the report: 

1. Numbers and descriptions of cases 

filed and complaints made on behalf of 

long-term care facility residents to the 

statewide ombudsman program; 

2. Major issues identified impacting 

on the quality of care and life of longterm care facility residents; 

3. Statewide program operations; and 

4. Ombudsman activities in addition 

to complaint investigation. 

The report form and instructions have 

been in continuous use, with minor 

modifications, since they were first 

approved by OMB for the FY 1995 

reporting period. This request is for 

approval to extend use of the current 

form and instructions, with no 

modifications, for three years, covering 

the FY 2012–2014 reporting periods. 

The data collected on complaints filed 

with ombudsman programs and 

narrative on long-term care issues 

provide information to Centers for 

Medicare and Medicaid Services and 

others on patterns of concerns and 

major long-term care issues affecting 

residents of long-term care facilities. 

Both the complaint and program data 

collected assist the states and local 

ombudsman programs in planning 

strategies and activities, providing 

training and technical assistance and 

developing performance measures. 

A reporting form and instructions 

may be viewed in the ombudsman 

section of the AoA Web site, 

www.aoa.gov. 

AoA estimates the burden of this 

collection and entering the report 

information as follows: Approximately 

8,569 hours, with 52 State Agencies on 

Aging responding annually. 

Dated: March 2, 2012. 

Kathy Greenlee, 

Assistant Secretary for Aging. 

[FR Doc. 2012–7219 Filed 3–23–12; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0624] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Notice of 

Participation 

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 April 25, 

2012. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 17483 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0191. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@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. 

Notice of Participation—21 CFR 12.45 

(OMB Control Number 0910–0191)— 

Extension 

Section 12.45 (21 CFR 12.45), issued 

under section 701 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 371), 

sets forth the format and procedures for 

any interested person to file a petition 

to participate in a formal evidentiary 

hearing, either personally or through a 

representative. Section 12.45 requires 

that any person filing a notice of 

participation state their specific interest 

in the proceedings, including the 

specific issues of fact about which the 

person desires to be heard. This section 

also requires that the notice include a 

statement that the person will present 

testimony at the hearing and will 

comply with specific requirements in 21 

CFR 12.85, or, in the case of a hearing 

before a Public Board of Inquiry, 

concerning disclosure of data and 

information by participants (21 CFR 

13.25). In accordance with § 12.45(e), 

the presiding officer may omit a 

participant’s appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the pre-hearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses, or other for-profit groups 

and institutions. 

In the Federal Register of September 

9, 2011 (76 FR 55918), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

12.45 .................................................................................... 4 1 4 3 12 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates for this 

collection of information are based on 

Agency records and experience over the 

past 3 years. 

Dated: March 20, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7137 Filed 3–23–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0776] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Reclassification 

Petitions for Medical Devices 

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 April 25, 

2012. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0138 and 

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. 

Reclassification Petitions for Medical 

Devices—21 CFR 860.123 (OMB Control 

Number 0910–0138)—Extension 

Under sections 513(e) and (f), 514(b), 

515(b), and 520(l) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360c(e) and (f), 360d(b), 360e(b), 

and 360j(l)) and part 860 (21 CFR part 

860), subpart C, FDA has responsibility 

to collect data and information 

contained in reclassification petitions. 

The reclassification provisions of the 

FD&C Act allow any person to petition 

for reclassification of a device from any 

of the three classes i.e., I, II, and III, to 

another class. The reclassification 

procedure regulation requires the 

submission of specific data when a 

manufacturer is petitioning for 

reclassification. This includes a 

‘‘Supplemental Data Sheet,’’ Form FDA 

3427, and a ‘‘Classification 

Questionnaire,’’ Form FDA 3429. Both 

forms contain a series of questions 

concerning the safety and effectiveness 

of the device type. Further, the 

reclassification content regulation 

(§ 860.123) requires the submission of 

valid scientific evidence demonstrating 

that the proposed reclassification will 

provide a reasonable assurance of safety 

and effectiveness of the device type for 

its indications for use. Thus, the 

reclassification provisions of the FD&C 

Act serve primarily as a vehicle for 

manufacturers to seek reclassification 

from a higher to a lower class, thereby 

reducing the regulatory requirements 

applicable to a particular device type, or 


tkelley on DSK3SPTVN1PROD with NOTICES