Submission for OMB Review; Comment Request, 35895-35896 [2011-15189]

Download as PDF 35895 Federal Register / Vol. 76, No. 118 / Monday, June 20, 2011 / Notices and Units of Local Government, 42 U.S.C. 15421). Each State or Unit of Local Government must prepare and submit an annual report at the end of every fiscal year. The report addresses the activities conducted with the funds provided during the year. The information collected from the annual report will be aggregated into an annual profile of how States have utilized the funds and establish best practices for election officials. It will also provide an overview of the State election goals and accomplishments and permit the Administration on Developmental Disabilities to track voting progress to monitor grant activities. Respondents Secretaries of State, Directors, State Election Boards, State Chief Election officials. ANNUAL BURDEN ESTIMATES Number of responses per respondent Number of respondents Instrument Help America Vote Act (HAVA) Voting Access Annual Report ...................... Help America Vote Act (HAVA) Voting Access Application ............................ Estimated Total Annual Burden Hours: 4,070. 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 55 55 Average burden hours per response 1 1 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. 2011–15115 Filed 6–17–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Reunification Procedures for Unaccompanied Alien Children. OMB No.: 0970–0278. Description Following the passage of the 2002 Homeland Security Act (Pub. L. 107– 24 50 Total burden hours 1,320 2,750. 296), the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is charged with the care and placement of unaccompanied alien children in Federal custody, and implementing a policy for the release of these children, when appropriate, upon the request of suitable sponsors while awaiting immigration proceedings. In order for ORR to make determinations regarding the release of these children, the potential sponsors must meet certain conditions pursuant to section 462 of the Homeland Security Act and the Flores v. Reno Settlement Agreement No. CV85 4544–RJK (C.D. Cal. 1997). The proposed information collection requests information to be utilized by ORR for determining the suitability of a sponsor/respondent for the release of a minor from ORR custody. The proposed instruments are the Sponsors Agreement to Conditions of Release, Verification of Release, Family Reunification Packet, and the Authorization for Release of Information. Respondents: Sponsors requesting release of unaccompanied alien. ANNUAL BURDEN ESTIMATES Number of respondents Instrument sroberts on DSK5SPTVN1PROD with NOTICES Verification of Release (UAC) ..................................................................... Authorization for Release of Information (Sponsor) .................................... Family Reunification Packet (Sponsor) ....................................................... Sponsors Agreement to Conditions of Release (Sponsor) ......................... Verification of Release (Case Worker) ........................................................ Authorization for Release of Information (Case Worker) ............................ Family Reunification Packet (Case Worker) ................................................ Sponsors Agreement to conditions of Release (Case Worker) .................. Estimated Total Annual Burden Hours: 16,082.50. Additional Information Copies of the proposed collection may be obtained by writing to the VerDate Mar<15>2010 16:50 Jun 17, 2011 Jkt 223001 Number of responses per respondent 4,595 4,595 4,595 4,595 4,595 4,595 4,595 4,595 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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 1 1 1 1 1 1 1 1 Average burden hours per response 0.25 0.25 1 0.25 0.25 0.25 1 0.25 Total burden hours 1,148.75 1,148.75 4,595 1,148.75 1,148.75 .......................... 4,595 1,148.75 identified by the title of the information collection. e-mail address: infocollection@acf.hhs.gov. E:\FR\FM\20JNN1.SGM 20JNN1 35896 Federal Register / Vol. 76, No. 118 / Monday, June 20, 2011 / Notices 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. Dated: March 29, 2011. Robert Sargis, Reports Clearance Officer. BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0447] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information resulting from the guidance to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to current good manufacturing practice (CGMP). DATES: Submit either electronic or written comments on the collection of information by August 19, 2011. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:24 Jun 17, 2011 FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: [FR Doc. 2011–15189 Filed 6–17–11; 8:45 am] AGENCY: Submit electronic comments on the collection of information to http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. ADDRESSES: Jkt 223001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice—(OMB Control Number 0910–0563)—Extension The guidance is intended to provide information to manufacturers of veterinary and human drugs, including human biological drug products, on how to resolve disputes of scientific and technical issues relating to CGMP. Disputes related to scientific and technical issues may arise during FDA inspections of pharmaceutical manufacturers to determine compliance with CGMP requirements or during FDA’s assessment of corrective actions undertaken as a result of such inspections. The guidance provides procedures that encourage open and prompt discussion of disputes and lead to their resolution. The guidance describes procedures for raising such disputes to the Office of Regulatory Affairs (ORA) and center levels and for requesting review by the dispute resolution (DR) panel. When a scientific or technical issue arises during an FDA inspection, the manufacturer should initially attempt to reach agreement on the issue informally with the investigator. Certain scientific or technical issues may be too complex or time consuming to resolve during the inspection. If resolution of a scientific or technical issue is not accomplished through informal mechanisms prior to the issuance of the FDA Form 483, the manufacturer can formally request DR and can use the formal two-tiered DR process described in the guidance. Tier one of the formal DR process involves scientific or technical issues raised by a manufacturer to the ORA and center levels. If a manufacturer disagrees with the tier one decision, tier two of the formal DR process would then be available for appealing that decision to the DR panel. The written request for formal DR to the appropriate ORA unit should be made within 30 days of the completion of an inspection and should include all supporting documentation and arguments for review, as described in this document. The written request for formal DR to the DR panel should be made within 60 days of receipt of the tier one decision and should include all supporting documentation and arguments, as described in the following paragraphs. All requests for formal DR should be in writing and include adequate information to explain the nature of the dispute and to allow FDA to act quickly and efficiently. Each request should be E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Notices]
[Pages 35895-35896]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Reunification Procedures for Unaccompanied Alien Children.
    OMB No.: 0970-0278.

Description

    Following the passage of the 2002 Homeland Security Act (Pub. L. 
107-296), the Administration for Children and Families (ACF), Office of 
Refugee Resettlement (ORR), is charged with the care and placement of 
unaccompanied alien children in Federal custody, and implementing a 
policy for the release of these children, when appropriate, upon the 
request of suitable sponsors while awaiting immigration proceedings. In 
order for ORR to make determinations regarding the release of these 
children, the potential sponsors must meet certain conditions pursuant 
to section 462 of the Homeland Security Act and the Flores v. Reno 
Settlement Agreement No. CV85 4544-RJK (C.D. Cal. 1997). The proposed 
information collection requests information to be utilized by ORR for 
determining the suitability of a sponsor/respondent for the release of 
a minor from ORR custody. The proposed instruments are the Sponsors 
Agreement to Conditions of Release, Verification of Release, Family 
Reunification Packet, and the Authorization for Release of Information.
    Respondents: Sponsors requesting release of unaccompanied alien.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                   Instrument                        Number of     responses per   burden hours    Total burden
                                                    respondents     respondent     per response        hours
----------------------------------------------------------------------------------------------------------------
Verification of Release (UAC)...................           4,595               1            0.25        1,148.75
Authorization for Release of Information                   4,595               1            0.25        1,148.75
 (Sponsor)......................................
Family Reunification Packet (Sponsor)...........           4,595               1            1           4,595
Sponsors Agreement to Conditions of Release                4,595               1            0.25        1,148.75
 (Sponsor)......................................
Verification of Release (Case Worker)...........           4,595               1            0.25        1,148.75
Authorization for Release of Information (Case             4,595               1            0.25  ..............
 Worker)........................................
Family Reunification Packet (Case Worker).......           4,595               1            1           4,595
Sponsors Agreement to conditions of Release                4,595               1            0.25        1,148.75
 (Case Worker)..................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 16,082.50.

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.

[[Page 35896]]

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.

    Dated: March 29, 2011.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-15189 Filed 6-17-11; 8:45 am]
BILLING CODE 4184-01-P