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

This final rule updates our display of approved control numbers for the collection of information that have been assigned to HCFA by the Office of Management and Budget (OMB). OMB regulations require each agency to include the approval numbers in the agency's rules.     

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.     

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.     

Quality management program and misadministrations; NRC override of OMB disapproval of NRC information collection request--Nuclear Regulatory Commission. Final rule

The Commission has voted to override the Office of Management and Budget (OMB) disapproval of the information collection requirements imposed in the final rule entitled "Quality Management Program and Misadministrations" (July 25, 1991; 56 FR 34104). As part of this final rule, the Commission is amending its regulations to reflect OMB's assignment of a new control number to these information collection requirements. The Commission reevaluated the need for this final rule and the information collection requirements it contains. The Commission continues to believe that its requirements for written quality management programs and misadministration reports, if complied with, have a reasonable likelihood of decreasing misadministrations (e.g., wrong dose or wrong patient) with a small incremental cost to licensees. Without the reporting and recordkeeping requirements, it would not be possible to implement and enforce these regulations effectively.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

Agency information collection activities: proposed collection; comment request--AHCPR. Notice

This notice announces the Agency for Health Care Policy and Research's. (AHCPR) intention to request the Office of Management and Budget (OMB) to allow a proposed information collection of the "Medical Expenditure Panel Survey--Insurance Component (MEPS-IC) for 1998 and 1999." In accordance with the Paperwork Reduction Act of 1995, Pub. L. 104-13 (44 U.S.C. 3506(c)(2)(A)), AHCPR invites the public to comment on this proposed information collection.     

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.     

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.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

Grants and cooperative agreements to state and local governments, universities, hospitals, and other non-profit organizations--USDA. Interim final rule

This interim final rule amendment is issued to implement the Single Audit Act Amendments of 1996 (Public Law 104-156, 110 Stat. 1396) and the June 24, 1997, revision of OMB Circular A-133, "Audits of States, Local Governments, and Non-Profit Organizations" and to replace the existing audit requirements that are superseded by Public Law 104-156 and the revised A-133.     

Medicare program; swing-bed program changes--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to hospital swing beds that was published on September 7, 1989 (54 FR 37270). The interim rule expanded the swing-bed program to encompass rural hospitals with 50 to 99 beds. It established requirements that approved swing-bed hospitals with more than 49 beds must meet. This rule establishes the interim rules as final regulations with changes. These changes are based on our review and consideration of the public comments.     

Medicare program; review of information collection and recordkeeping requirements for providers of outpatient physical therapy and/or speech pathology services--HCFA. Final rule

This final rule changes several regulations to reduce information collection and recordkeeping requirements. The requirements, which were identified by the Office of Management and Budget, are contained primarily in the Medicare conditions of participation for providers of outpatient physical therapy and outpatient speech pathology services, and the Medicare conditions for coverage of the services of physical therapists in independent practice. The purpose of this rule is to remove or make modification of those information collection and recordkeeping requirements and to explain the basis for retaining others.