Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Notice of Participation, 17482-17483 [2012-7137]

Download as PDF 17482 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices Ms. Dana Munson, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone (202) 357– 9652 or via email to dana.munson@gsa.gov. FOR FURTHER INFORMATION CONTACT: Submit comments identified by Information Collection 3090–0262, Identification of Products with Environmental Attributes, by any of the following methods: • Regulations.gov: https:// 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 https:// www.regulations.gov, including any personal and/or business confidential information provided. SUPPLEMENTARY INFORMATION: ADDRESSES: tkelley on DSK3SPTVN1PROD with NOTICES 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. VerDate Mar<15>2010 19:32 Mar 23, 2012 Jkt 226001 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 Administration on Aging, HHS. Notice. AGENCY: ACTION: 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; SUMMARY: PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 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. 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. SUMMARY: E:\FR\FM\26MRN1.SGM 26MRN1 17483 Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Notices 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. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: 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 1 There 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. tkelley on DSK3SPTVN1PROD with NOTICES ACTION: Notice. 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. SUMMARY: VerDate Mar<15>2010 19:32 Mar 23, 2012 Jkt 226001 Fax written comments on the collection of information by April 25, 2012. DATES: 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. ADDRESSES: 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, PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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 E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17482-17483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7137]

-----------------------------------------------------------------------

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.

[[Page 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 Sec. 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
12.45.............................................................. 4 1 4 3 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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

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