Department of Health and Human Services March 5, 2012 – Federal Register Recent Federal Regulation Documents
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Proposed Collection: Comment Request Post-Award Reporting Requirements Including New Research Performance Progress Report Collection
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Public Health Service (PHS) Post-award Reporting Requirements. Type of Information Collection Request: Revision. This collection represents a consolidation of post-award reporting requirements under the PRA, and includes the new Research Performance Progress Report (RPPR). Need and Use of Information Collection: The RPPR will replace existing interim performance reports used by all NIH, Food and Drug Administration, Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. The phased transition to the RPPR requires the maintenance of dual reporting processes for a period of time. Thus this information collection is for the new use of the RPPR, and continued use of the PHS Non-competing Continuation Progress Report (PHS 2590, currently approved under 0925-0001), and the NIH AHRQ Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Progress Report for Continuation Support (PHS 416-9, currently approved under 0925-0002). Only one interim progress report (RPPR or PHS2590/416-9) will be utilized for any given award. This collection also includes other PHS post-award reporting requirements: PHS 416-7 NRSA Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, (currently approved under 0925-0002, expiration 6/30/2012); and HHS 568 Final Invention Statement and Certification, Final Progress Report instructions, and iEdison, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant (currently approved under 0925-0001, expiration 6/30/2012). The PHS 416-7, 2271, and 6031-1 are used by NRSA recipients to activate, terminate, and provide for payback of a NRSA. Close-out of an award requires a Final Invention Statement (HHS 568) and Final Progress Report. iEdison allows grantees and Federal agencies to meet statutory requirements for reporting inventions and patents. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. Pre-award reporting requirements are simultaneously consolidated under 0925-0001. Frequency of response: Grantees are required to report annually. Affected Public: Universities and other research institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal investigators. The annual reporting burden is as follows: Total Estimated Number of Respondents: 112,986. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: 5.6. Estimated Total Annual Burden Hours Requested: 640,677. The annualized cost to respondents is estimated to be $22,423,709. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency'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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Proposed Collection: Comment Request; Revision “PHS Applications and Pre-Award Reporting Requirements”
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act (PRA) of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Public Health Service (PHS) Applications and Pre-award Reporting Requirements. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 6/30/2012. Form numbers: PHS 398, PHS416-1, 416-5, and PHS 6031. This collection represents a consolidation of PHS applications and pre-award reporting requirements into a revised data collection under the PRA. Need and Use of Information Collection: This collection includes PHS applications and pre-award reporting requirements: PHS 398 [paper] Public Health Service Grant Application forms and instructions; PHS 398 [electronic] PHS Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application [paper]; Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic) is currently approved under 0925-0001; PHS 416-1, 416-5, and PHS 6031 are currently approved under 0925-0002. All forms expire 6/30/2012. Post-award reporting requirements are simultaneously consolidated under 0925-XXXX, and include the new Research Performance Progress Report (RPPR). The PHS 398 application is used by applicants to request Federal assistance funds for traditional investigator-initiated research projects and to request access to databases and other PHS resources. The PHS 416-1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency specific instructions is used in combination with the SF424 (R&R) forms/instructions for Fellowships and is used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416-5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify agreement to fulfill the payback provisions. Frequency of response: Applicants may submit applications for published receipt dates. For NRSA awards, fellowships are activated and trainees appointed. Affected Public: Universities and other research institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal professionals. The annual reporting burden is as follows: Total Estimated Number of Respondents: 94,326; Estimated Number of Responses per Respondent: 1, Average Burden Hours Per Response: 21.75; Estimated Total Annual Burden Hours Requested: 2,051,794. The estimated annualized cost to respondents is $71,812,769. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency'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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Advisory Committees; Filing of Closed Meeting Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2011.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding two closed sessions by teleconference under exemption 9(B) of the Government in Sunshine Act, 5 U.S.C. section 552b(c).
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