Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 45053-45054 [E7-15614]

Download as PDF Federal Register / Vol. 72, No. 154 / Friday, August 10, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions andDelegation of Authority Notice is hereby given that I have redelegated to the Director, Division of State Temporary Assistance for Needy Families (TANF) Policy with respect to State and territorial programs, and to the Director, Division of Tribal TANF Management with respect to tribal programs, the following authorities invested in me by the Director, Office of Family Assistance, in the memoranda dated April 17, 2007. sroberts on PROD1PC70 with PROPOSALS (a) Authorities Delegated 1. The authority to respond to general inquiries about established State and territorialTANF programs, territorial Adult Assistance Programs, and Tribal TANF and NativeEmployment Works (NEW) programs, to explain existing program policies for these programs, and to suggest referrals, when appropriate, to other government agencies and private organizations. 2. The authority to clarify and interpret existing Adult Assistance, TANF and NEW program policies and procedures affecting, where applicable, State, territorial, and tribal grantees. 3. The authority to deem State and territorial TANF plans as complete. 4. The authority to approve plans and amendments for the Tribal TANF and NEW programs. 5. The authority to provide and approve comments on State, territorial, and tribal corrective compliance plans submitted in response to a TANF penalty determination. 6. The authority to respond to inquiries about discretionary grants for the Tribal TANF—Child Welfare initiative. (b) Limitations 1. This delegation of authority shall be exercised under the Department’s existing policies on delegations and regulations. 2. The authority to respond to general inquiries relative to established State, territorial, and tribal programs or to inquire about specific grantee policies and operations requires notification to the appropriate TANF Regional Program Manager of the response given. 3. The authority to clarify and interpret existing program policies and procedures requires prior consultation with the Associate Director, TANF and the Director, OFA if such clarifications and interpretations are likely to have a VerDate Aug<31>2005 16:37 Aug 09, 2007 Jkt 211001 significant impact on States, territories, and tribes or have political ramifications or be subject to adverse publicity. 4. The authority to deem State TANF plans as complete requires prior consultation with the appropriate TANF Regional Program Manager. 5. The authority to approve Tribal TANF and NEW plans and amendments requires prior consultation with the appropriate TANF Regional Program Manager. 6. The authority to provide and approve comments on State, territorial, and tribal corrective compliance plans requires prior consultation with the appropriate TANF Regional Program Manager. 7. The authority to respond to inquiries about discretionary grants for the Tribal TANF—Child Welfare initiative requires prior consultation with the Associate Director, TANF on any responses that establish a new precedent or have political implications. (c) Effective Date This delegation is effective upon the date of signature. (d) Effect on Existing Delegations This delegation of authority supersedes the February 10, 2003 delegations of authority to approve Tribal TANF and NEW plans to the Director, Division of Tribal TANF Management. This delegation is in addition to the authority contained in the redelegation dated June 8, 2007 to the TANF Regional Program Managers. I hereby affirm and ratify any actions taken by the Director, Division of State TANF Policy and the Director, Division of Tribal TANF Management, Office of Family Assistance, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Date: July 18, 2007. Katherine Bradley, Associate Director, TANF. [FR Doc. E7–15721 Filed 8–9–07; 8:45 am] BILLING CODE 4184–01–P ACTION: 45053 Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Environmental Impact Considerations’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1482. SUPPLEMENTARY INFORMATION: In the Federal Register of September 22, 2006 (71 FR 55484), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0322. The approval expires on January 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Dated: August 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–15612 Filed 8–9–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0104] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0105] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Environmental Impact Considerations AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief E:\FR\FM\10AUN1.SGM 10AUN1 45054 Federal Register / Vol. 72, No. 154 / Friday, August 10, 2007 / Notices Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1482. DEPARTMENT OF HEALTH AND HUMAN SERVICES In the Federal Register of December 13, 2006 (71 FR 74924), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0530. The approval expires on May 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. Request for Public Comment: 60-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program SUPPLEMENTARY INFORMATION: Dated: August 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–15614 Filed 8–9–07; 8:45 am] BILLING CODE 4160–01–S Indian Health Service Indian Health Service, HHS. Notice. AGENCY: ACTION: SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917– 0006, ‘‘Application for Participation in the IHS Scholarship Program.’’ Type of Information Collection Request: Threeyear extension, without change of currently approved information collection, 0917–0006, ‘‘Application for Participation in the IHS Scholarship Program.’’ Form Number(s): IHS–856, 856–2 through 856–8, IHS–815, IHS– 816, IHS–817, IHS–818, D–02, F–02, F– Number of respondents Data collection instruments(s) Responses per respondent 04, G–02, G–04, H–07, H–08, J–04, J–05, K–03, K–04, and L–03. Reporting formats are contained in an IHS Scholarship Program application booklet. Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to solicit, process, and award IHS Pregraduate, Preparatory, and/or Health Professions Scholarship grants and monitor the academic performance of awardees and to place awardees at payback sites. The IHS Scholarship Program is streamlining the application to reduce the time needed by applicants to complete and provide the information. The IHS Scholarship Program plans on using information technology to make the application electronically available on the internet. Affected Public: Individuals, not-forprofit institutions and State, local or tribal government. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s). Total annual response Scholarship Application (IHS–856) .............................. Checklist (856–2) ......................................................... Course Verification (856–3) ......................................... Faculty/Employer Application (856–4) ......................... Justification (856–5) ..................................................... Federal Debt (856–6) ................................................... Job Experience (856–7) ............................................... Accept/Decline (856–8) ................................................ Receipt of Application (815) ........................................ Address Change Notice (816) ..................................... Scholarship Program Agreement (817) ....................... Health Professions Contract (818) .............................. Stipend Check (D–02) ................................................. Enrollment (F–02) ........................................................ Academic Problem/Change (F–04) ............................. Request Assistance (G–02) ......................................... Summer School (G–04) ............................................... Placement (H–07) ........................................................ Graduation (H–08) ....................................................... Site Preference (J–04) ................................................. Travel Reimb (J–05) .................................................... Status Report (K–03) ................................................... Preferred Assignment (K–04) ...................................... Request of Deferment (L–03) ...................................... 1500 1500 1500 1500 1500 1500 25 650 1500 25 850 650 100 1300 50 217 193 250 250 150 150 250 200 20 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1500 1500 1500 3000 1500 1500 25 650 1500 25 850 650 100 1300 50 217 193 250 250 150 150 250 200 20 Total ...................................................................... 15,830 ............................ ........................ Burden hour per response * 1.00 (60 0.13 (8 0.70 (42 0.83 (50 0.75 (45 0.13 (8 0.83 (50 0.13 (8 0.03 (2 0.02 (1 0.05 (3 0.05 (3 0.13 (8 0.13 (8 0.13 (8 0.13 (8 0.10 (6 0.18 (11 0.17 (10 0.13 (8 0.10 (6 0.25 (15 0.75 (45 0.13 (8 Annual burden hours min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) min) 1500 195 1050 2490 1125 195 21 84 45 25 43 33 13 169 6 28 19 45 43 20 15 63 150 3 ............................ 7,380 sroberts on PROD1PC70 with PROPOSALS * For ease of understanding, burden hours are also provided in actual minutes. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Request for Comments: Your written comments and/or suggestions are VerDate Aug<31>2005 16:37 Aug 09, 2007 Jkt 211001 invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 collected in a useful and timely fashion; (c) the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (d) E:\FR\FM\10AUN1.SGM 10AUN1

Agencies

[Federal Register Volume 72, Number 154 (Friday, August 10, 2007)]
[Notices]
[Pages 45053-45054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0104]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Requirements for Submission of 
Labeling for Human Prescription Drugs and Biologics in Electronic 
Format

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Requirements for Submission of 
Labeling for Human Prescription Drugs and Biologics in Electronic 
Format'' has been approved by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief

[[Page 45054]]

Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 13, 2006 
(71 FR 74924), the agency announced that the proposed information 
collection had been submitted to OMB for review and clearance under 44 
U.S.C. 3507. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number. OMB has now approved the 
information collection and has assigned OMB control number 0910-0530. 
The approval expires on May 31, 2010. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.fda.gov/ohrms/dockets.

    Dated: August 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15614 Filed 8-9-07; 8:45 am]
BILLING CODE 4160-01-S

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