Office of Management and Budget control numbers under the Paperwork Reduction Act--OSHA. Final rule

The Occupational Safety and Health Administration (OSHA) is adding new sections to its Safety and Health REgulations for General Industry, Construction and Shipyard Employment. These new sections will be used to consolidate and display all of the control numbers assigned by the Office of Management and Budget (OMB) for "approved" information collection requirements. OSHA is also identifying information collection requirements found in certain of its other regulations and displaying the OMB control number at the end of each section containing a collection of information. None of the requirements are new; they have been promulgated by OSHA at various times over the past 25 years. The display of OMB control numbers is required under the implementing rules and regulations of OMB and under the Paperwork Reduction Act of 1995.     

Administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations; direct grant programs--DoE. Final regulations

The Secretary amends 34 CFR parts 74 and 75 to add the Office of Management and Budget (OMB) control numbers to certain sections of the regulations. Those sections contain information collection requirements approved by OMB. The Secretary takes this action to inform the public that these requirements have been approved.     

Attestations by facilities using nonimmigrant aliens as registered nurses--Employment and Training Administration and Employment Standards Administration, Labor--Final rule and amendment and announcement of effective date

On January 6, 1994, the Employment and Training Administration (ETA) and the Wage and Hour Division of the Employment Standards Administration of the Department of Labor published final regulations governing the filing and enforcement of attestations by health care facilities seeking to use the services of nonimmigrant aliens as registered nurses under H-1A visas. At that time, ETA submitted the information collection requirements to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980. This document amends the January 6, 1994, Federal Register document to display the OMB control numbers and announces the effective date for the sections containing information collection requirements for which OMB approval has been received.     

Medicare and Medicaid programs; approved information collection requirements and HCFA's claims collection authority--HCFA. Final rule with comment period

This final rule updates our display of control numbers assigned by the Office of Management and Budget (OMB) to approved "collection of information" requirements contained in regulations governing the Medicare and Medicaid programs. In addition, it incorporates a technical change to our regulations to reflect increased agency authority under the Federal Claims Collection Act, 31 U.S.C. 3711 et seq. This rule is issued in accordance with OMB regulations concerning approved collections of information and to conform to changes made by Public Law 101-552.     

Occupational exposure to bloodborne pathogens; approval of information collection requirements--OSHA. Final rule; approval of information collection requirements

On December 6, 1991, OSHA published a final standard governing occupational exposure to bloodborne pathogens (56 FR 64004). The standard is designed to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) and other bloodborne pathogens. At that time OSHA submitted the information collection requirements to the Office of Management and Budget (OMB) for review under section 3504(h) of the Paperwork Reduction Act (PRA) of 1980. Public reporting burden for this collection of information was estimated to average five minutes per employer response to an OSHA compliance officer's request for access to the employer's records. OMB reviewed the collection of information requirements for occupational exposure to bloodborne pathogens in accordance with the PRA, 44 U.S.C. 3501 et seq., and 5 CFR part 1320. OMB approved all information requirements contained in 29 CFR 1910.1030 under OMB clearance number 1218-0180. The OMB clearance expires on February 28, 1995. This document will also amend the December 6, 1991 rule to properly display the OMB control number.     

Protection for subjects in human research. Final rule

With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9.     

Miscellaneous amendments--HHS. Final rule

This final rule will remove appendixes I and J, which contain the test of Office Management and Budget (OMB) Circulars A-128 and A-133, from 45 CFR part 74. It will also update several items to conform them to the Federal Acquisition Streamlining Act of 1994 and correct a confusing statement which resulted from two typographical errors in that portion of OMB Circular A-110 upon which this statement is based.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals and other non-profit organizations--OMB. Final revision to OMB circular A-110

Office of Management and Budget (OMB) Circular A-110 provides standards for obtaining consistency and uniformity among Federal agencies in the administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations. OMB issued Circular A-110 in 1976 and, except for a minor revision in February 1987, the Circular contains its original provisions. To update the Circular, OMB established an interagency task force to review the Circular. The task force solicited suggestions for changes to the Circular from university groups, non-profit organizations and other interested parties and compared, for consistency, the provisions of similar provisions applied to State and local governments. The revised Circular reflects the results of these efforts.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals and other non-profit organizations, and with commercial organizations, foreign governments, organizations under the jurisdiction of foreign governments, and international organizations--DOL. Final rule

The Department of Labor is issuing these regulations pursuant to the requirements of the Office of Management and Budget (OMB) Circular No. A-110 (Revised), which provides standards for obtaining consistency and uniformity among Federal agencies in the administration of grants and agreements with institutions of higher education, hospitals, and other non-profit organizations. This rule also applies to the Department of Labor's grants to commercial organizations, foreign governments, organizations under the jurisdiction of foreign governments and international organizations. OMB issued Circular A-110 in 1976 and, except for a minor revision in February 1987, the Circular remained unchanged until revised in 1993. To update the Circular, OMB established an interagency task force to review the Circular. The task force solicited suggestions for changes to the Circular from university groups, non-profit organizations and other interested parties and compared for consistency the provisions of similar provisions applied to State and local governments. The revised Circular and these regulations reflect the results of these efforts.     

Privacy Act of 1974; system of records--PHS. Notification of a new system of records: 09-30-0046, "Survey of alcohol use among youth and young adults"

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records entitled, "Survey of Alcohol Use Among Youth and Young Adults, HHS/ADAMHA/NIAAA," to create a single comprehensive research data base so that critical issues associated with alcohol use among 16- to 27-year-olds can be analyzed. PHS invites interested persons to submit comments on the proposed routine uses on or before March 19, 1984. DATES: PHS has sent a Report of a New System to the Congress and to the Office of Management and Budget (OMB) on Februrary 8, 1984 PHS has requested that OMB grant a waiver of the usual requirement that a system of records not be put into effect until 60 days after the report is sent to OMB and Congress (If this waver is granted, PHS will publish a notice to that effect in the Federal Register.)     

Privacy Act of 1974; system of records--PHS. Waiver of advance notice period for a new system of records

FR Doc. 83-18581, appearing at page 31738 in the issue of Monday, July 11, 1983, provided notification of a new system of records proposed by the Health Resources and Services Administration (HRSA). That system is 09-15-0045, "Health Resources and Services Administration Loan Repayment/Debt Management Records System, HHS/HRSA/OA." The document stated that the Public Health Service had requested that the Office of Management and Budget (OMB) grant a waiver of the usual requirement that a system of records not be put into effect until 60 days after the report is sent to OMB and the Congress OMB granted the requested waiver on August 3, 1983. Accordingly, the new system of records, 09-15-0045, became effective upon the date of the waiver except for the routine uses established for the system. They became effective August 11, 1983, following the public comment period. However, in response to a comment received from the responsible oversight committee of the U.S. House of Representatives, we are adding a routine use to permit disclosure of information from these records to the General Accounting Office (GAO) and OMB for auditing financial obligations. We are also modifying one of the existing routine uses. PHS invites interested parties to submit comments on the proposed new routine use on or before September 29, 1983. In accordance with the Debt Collection Act of 1982 (Pub. L. 97-365), we are also adding the "special disclosure" statement. This statement does not require a public comment period.     

Block grant programs: implementation of OMB Circular A-133--HHS. Interim final rule with request for comments

This interim final rule implements Office of Management and Budget (OMB) Circular A-133 for Department of Health and Human Services (HHS) block programs.     

Medical devices; implementation of third party review under the Food and Drug Administration Modernization Act of 1997; emergency processing request under OMB review--FDA. Notice

The Food and Drug Administration (FDA) is announcing a program under which persons may be accredited to review premarket notifications and recommend initial classification of certain medical devices. At the same time, FDA is announcing the termination of the Third Party Review Pilot Program. This notice announces the criteria to accredit or deny accreditation to persons (Accredited Persons) who request to conduct premarket notification reviews consistent with provisions of the FDA Modernization Act of 1997 (FDAMA). FDA is also announcing that this proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is requesting OMB approval within 45 days of receipt of this submission. FDA is taking this action to implement section 210 of FDAMA. The availability of guidance detailing the review of submissions, training for third party reviewers, and basic document processing by FDA is announced elsewhere in this tissue of the Federal Register.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, other non-profit, and commercial organizations--Department of Commerce. Interim final rule

This interim final rule implements the revisions to the Office of Management and Budget (OMB) Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations" which was published in the Federal Register on November 29, 1993. The revised Circular was developed by an interagency task force for governmentwide use in a model rule format to facilitate regulatory adoption by executive departments and agencies. In the published revised Circular, OMB specified as "required action" that Federal agencies responsible for awarding and administering grants and other agreements to recipients described therein, shall adopt the language of the Circular unless other provisions are required by Federal statute or exceptions or deviations are approved by OMB. This interim final rule adopts the provisions of the Circular and its language to the maximum extent feasible. However, minor changes were made to update the procedures, clarify the language, and make the language apply specifically to the DoC and its operating units. No changes are intended to deviate from the substance of Circular A-110. The Circular covers both grants and cooperative agreements made by Federal agencies and subawards, unless sections of the Circular specifically exclude subrecipients from coverage. Consistent with guidance provided in the Circular, DoC will apply its provisions to grants and agreements with institutions of higher education, hospitals, other nonprofit, and commercial organizations. The provisions of the interim final rule will also apply to foreign governments, organizations under the jurisdiction of foreign governments, and international organizations when appropriate.     

Agency information collection activities; announcement of OMB approval; medical devices: third-party review program under the U.S./EC MRA. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Medical Devices: Third-Party Review Program Under the U.S./EC MRA" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.     

Regulatory Science and the Data Quality Act

The importance of data quality was highlighted in an amendment attached to a 2000 law enacted by the 106th U.S. Congress. The law known as the “Data Quality Act” or the “Information Quality Act,” mandated that the Office of Management and Budget (OMB) issue guidance to federal agencies for “ensuring and maximizing the quality, objectivity, utilility, and integrity of information (including statistical information) disseminated by federal agencies.” In turn, OMB required more than 90 federal agencies such as the United States Environmental Protection Agency (EPA) to implement data quality guidelines. These guidelines have created a rigorous, if not rancorous, debate within the regulated community. This paper will provide a brief synopsis of the evolution of the Act, discuss how the Act and scientific uncertainty interrelate, and review the status of the Act's petition process for correcting government disseminated information.     

Agency information collection activities; announcement of OMB approval; Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Food Labeling: Nutrition Labeling of Dietary Supplements on a "Per Day" Basis" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.     

Cost allocation methodology applicable to the temporary assistance for needy families program. Final rule

This final rule applies to the Temporary Assistance for Needy Families (TANF) program and requires States, the District of Columbia and the Territories (hereinafter referred to as the "States") to use the "benefiting program" cost allocation methodology in U.S. Office of Management and Budget (OMB) Circular A-87 (2 CFR part 225). It is the judgment and determination of HHS/ACF that the "benefiting program" cost allocation methodology is the appropriate methodology for the proper use of Federal TANF funds. The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave federally-recognized Tribes the opportunity to operate their own Tribal TANF programs. Federally-recognized Indian tribes operating approved Tribal TANF programs have always followed the "benefiting program" cost allocation methodology in accordance with OMB Circular A-87 (2 CFR part 225) and the applicable regulatory provisions at 45 CFR 286.45(c) and (d). This final rule contains no substantive changes to the proposed rule published on September 27, 2006.     

Medical devices; reports of corrections and removals; lift of stay of effective date--FDA. Final rule; lift of stay of effective date

The Food and Drug Administration (FDA) is lifting a stay of the effective date of certain provisions in a final rule on establishing procedures for submission of reports of corrections and removals of medical devices. The Office of Management and Budget (OMB) has approved the collection of information requirements contained in the final rule.