Agency Information Collection Activities: Submission for OMB Review; Comment Request, 28048-28049 [E9-13841]

Download as PDF 28048 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices can be obtained by contacting FASAB at (202) 512–7350. Respondents are encouraged to comment on any part of the exposure draft. Written comments are requested by July 17, 2009, and should be sent to: Wendy M. Payne, Executive Director, Federal Accounting Standards Advisory Board, 441 G Street, NW., Suite 6814, Mail Stop 6K17V, Washington, DC 20548. FOR FURTHER INFORMATION CONTACT: Wendy Payne, Executive Director, 441 G Street, NW., Washington, DC 20548, or call (202) 512–7350. Authority: Federal Advisory Committee Act, Public Law 92–463. Dated: June 8, 2009. Charles Jackson, Federal Register Liaison Officer. [FR Doc. E9–13803 Filed 6–11–09; 8:45 am] In the Federal Register Notice of June 3, 2009, in FR Doc. E9–12951, on page 26700, in the third column, under the heading ‘‘CATEGORIES OF RECORDS IN THE SYSTEM’’ remove ‘‘DHA’’ and add ‘‘DHS’’ in its place. Dated: June 8, 2009. Kim Mott, Privacy Act Officer. [FR Doc. E9–13830 Filed 6–11–09; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request BILLING CODE 1610–01–M GENERAL SERVICES ADMINISTRATION Privacy Act of 1974; Notice of Updated Systems of Records; Correction AGENCY: General Services Administration. ACTION: Correction. SUMMARY: GSA is issuing a correction to the notice GSA/GOVT–4 Contracted Travel Services Program. The document contained an incorrect acronym. GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and compliant with OMB M– 07–16. DATES: Effective June 12, 2009. FOR FURTHER INFORMATION CONTACT: Call or e-mail the GSA Privacy Act Officer: telephone 202–208–1317; e-mail gsa.privacyact@gsa.gov. ADDRESSES: GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street NW., Washington, DC 20405. Correction: Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: Projects for Assistance in Transition From Homelessness (PATH) Program Annual Report (OMB No. 0930–0205)—Revision The Center for Mental Health Services awards grants each fiscal year to each of the States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands from allotments authorized under the PATH program established by Public Law 101–645, 42 U.S.C. 290cc–21 et seq., the Stewart B. McKinney Homeless Assistance Amendments Act of 1990 (section 521 et seq. of the Public Health Service (PHS) Act). Section 522 of the PHS Act requires that the grantee States and Territories must expend their payments under the Act solely for making grants to political subdivisions of the State, Number of respondents Respondents States ............................................................................................................... Local provider agencies ................................................................................... Totals ........................................................................................................ Written comments and recommendations concerning the proposed information collection should be sent by July 13, 2009 to: SAMHSA VerDate Nov<24>2008 17:53 Jun 11, 2009 Jkt 217001 56 480 536 Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 and to non-profit private entities (including community-based veterans’ organizations and other community organizations) for the purpose of providing services specified in the Act. Available funding is allotted in accordance with the formula provision of section 524 of the PHS Act. This submission is for a revision of the current approval of the annual grantee reporting requirements. Section 528 of the PHS Act specifies that not later than January 31 of each fiscal year, a funded entity will prepare and submit a report in such form and containing such information as is determined necessary for securing a record and description of the purposes for which amounts received under section 521 were expended during the preceding fiscal year and of the recipients of such amounts and determining whether such amounts were expended in accordance with statutory provisions. The proposed changes to the PATH Annual Report Survey are as follows: • Reporting on all persons served with PATH Federal and matching State funds. Additional Optional Questions: Table C • The number of Enrolled consumers placed into housing (Transitional, Supportive, or Permanent). • The number of Enrolled consumers who were assisted with successfully obtaining income benefits (SSI, SSDI, VA, etc.). • The number of Enrolled consumers who were assisted with successfully obtaining or increasing their earned income (employment). • The number of Enrolled consumers who were assisted with successfully obtaining medical insurance or coverage plans (Medicaid, Medicare, and/or State/local plans). • The number of Enrolled consumers who were assisted with successfully obtaining primary medical care. The estimated annual burden for these reporting requirements is summarized in the table below. Responses per respondent Burden per response (hrs.) 1 1 ........................ 26 31 ........................ Total burden 1,456 14,880 16,336 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, E:\FR\FM\12JNN1.SGM 12JNN1 Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Notices respondents are encouraged to submit comments by fax to: 202–395–6974. Dated: June 4, 2009. Elaine Parry, Director, Office of Program Services. [FR Doc. E9–13841 Filed 6–11–09; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0137] Mary E. Sawaya a.k.a. Marty Sawaya; Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Dr. Mary E. Sawaya a.k.a. Marty Sawaya (Dr. Sawaya) from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Sawaya was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Sawaya failed to request a hearing. Dr. Sawaya’s failure to request a hearing constitutes a waiver of her right to a hearing concerning this action. DATES: This order is effective June 12, 2009. ADDRESSES: Submit applications for special termination of debarment to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Robert L. Hummel, Sr., Division of Compliance Policy (HFC–230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240–632–6845. SUPPLEMENTARY INFORMATION: I. Background Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires debarment of an individual if FDA finds that the VerDate Nov<24>2008 17:53 Jun 11, 2009 Jkt 217001 28049 individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Section 306(a)(2)(B) of the act requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of any drug product under the act. On December 11, 2003, the U.S. District Court for the Middle District of Florida accepted Dr. Mary E. Sawaya’s plea of guilty and convicted her of one count of making a false statement to a Federal agency, a Federal felony offense under 18 U.S.C. 1001. This offense was committed when Dr. Sawaya created a medical license by obtaining a copy of a colleague’s Florida medical license, altered that license using a photocopy machine to reflect that the license was issued in her name, and submitted the false and fraudulent Florida medical license to the sponsor of a clinical trial, for which she was a clinical investigator. The sponsor submitted that license to FDA as part of the drug approval process. When the false license was due to expire, Dr. Sawaya once again created a false and fraudulent medical license with a different expiration date and submitted that license to the clinical trial sponsor. As a result of this conviction, FDA sent Dr. Sawaya by certified mail on November 26, 2008, a notice proposing to permanently debar her from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(A) and (a)(2)(B) of the act, that Dr. Sawaya was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and conduct otherwise relating to the regulation of a drug product under the act. The proposal also offered Dr. Sawaya an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Dr. Sawaya did not request a hearing and has, therefore, waived her opportunity for a hearing and any contentions concerning her debarment (21 CFR part 12). Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the act, and under authority delegated to her, finds that Dr. Sawaya has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product and conduct otherwise relating to the regulation of a drug product under the act. As a result of the foregoing finding, Dr. Sawaya is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES). (See sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 321(dd)).) Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Dr. Sawaya, in any capacity, during Dr. Sawaya’s permanent debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Dr. Sawaya , during her period of debarment, provides services in any capacity to a person with an approved or pending drug product application, she will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Dr. Sawaya during her period of debarment (section 306(c)(1)(B) of the act). Any application by Dr. Sawaya for special termination of debarment under section 306(d)(4) of the act should be identified with Docket No. FDA–2008– N–0137 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. II. Findings and Order Therefore, the Acting Director, Office of Enforcement, Office of Regulatory BILLING CODE 4160–01–S PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Dated: June 1, 2009. Alyson L. Saben, Acting Director, Office of Enforcement, Office of Regulatory Affairs. [FR Doc. E9–13929 Filed 6–11–09; 8:45 am] E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 74, Number 112 (Friday, June 12, 2009)]
[Notices]
[Pages 28048-28049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

Project: Projects for Assistance in Transition From Homelessness (PATH) 
Program Annual Report (OMB No. 0930-0205)--Revision

    The Center for Mental Health Services awards grants each fiscal 
year to each of the States, the District of Columbia, the Commonwealth 
of Puerto Rico, the Virgin Islands, Guam, American Samoa, and the 
Commonwealth of the Northern Mariana Islands from allotments authorized 
under the PATH program established by Public Law 101-645, 42 U.S.C. 
290cc-21 et seq., the Stewart B. McKinney Homeless Assistance 
Amendments Act of 1990 (section 521 et seq. of the Public Health 
Service (PHS) Act). Section 522 of the PHS Act requires that the 
grantee States and Territories must expend their payments under the Act 
solely for making grants to political subdivisions of the State, and to 
non-profit private entities (including community-based veterans' 
organizations and other community organizations) for the purpose of 
providing services specified in the Act. Available funding is allotted 
in accordance with the formula provision of section 524 of the PHS Act.
    This submission is for a revision of the current approval of the 
annual grantee reporting requirements. Section 528 of the PHS Act 
specifies that not later than January 31 of each fiscal year, a funded 
entity will prepare and submit a report in such form and containing 
such information as is determined necessary for securing a record and 
description of the purposes for which amounts received under section 
521 were expended during the preceding fiscal year and of the 
recipients of such amounts and determining whether such amounts were 
expended in accordance with statutory provisions.
    The proposed changes to the PATH Annual Report Survey are as 
follows:
     Reporting on all persons served with PATH Federal and 
matching State funds.
    Additional Optional Questions:

Table C

     The number of Enrolled consumers placed into housing 
(Transitional, Supportive, or Permanent).
     The number of Enrolled consumers who were assisted with 
successfully obtaining income benefits (SSI, SSDI, VA, etc.).
     The number of Enrolled consumers who were assisted with 
successfully obtaining or increasing their earned income (employment).
     The number of Enrolled consumers who were assisted with 
successfully obtaining medical insurance or coverage plans (Medicaid, 
Medicare, and/or State/local plans).
     The number of Enrolled consumers who were assisted with 
successfully obtaining primary medical care.
    The estimated annual burden for these reporting requirements is 
summarized in the table below.

----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per
                   Respondents                       Number of     Responses per     response      Total burden
                                                    respondents     respondent        (hrs.)
----------------------------------------------------------------------------------------------------------------
States..........................................              56               1              26           1,456
Local provider agencies.........................             480               1              31          14,880
    Totals......................................             536  ..............  ..............          16,336
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by July 13, 2009 to: SAMHSA Desk 
Officer, Human Resources and Housing Branch, Office of Management and 
Budget, New Executive Office Building, Room 10235, Washington, DC 
20503; due to potential delays in OMB's receipt and processing of mail 
sent through the U.S. Postal Service,

[[Page 28049]]

respondents are encouraged to submit comments by fax to: 202-395-6974.

    Dated: June 4, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-13841 Filed 6-11-09; 8:45 am]
BILLING CODE 4162-20-P
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