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.     

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.     

Medicare program; prospective payment system for hospital outpatient services; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This notice extends the comment period for a proposed rule published in the Federal Register on September 8, 1998, (63 FR 47552). In that rule, as required by sections 4521, 4522, and 4523 of the Balanced Budget Act of 1997, we proposed to eliminate the formula-driven overpayment for certain outpatient hospital services, extend reductions in payment for costs of hospital outpatient services, and establish in regulations a prospective payment system for hospital outpatient services (and for Medicare Part B services furnished to inpatients who have no Part A coverage.) The comment period is extended for 60 days.     

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.     

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.     

Project grants for migrant health; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Migrant Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, make former migratory agricultural workers who are disabled eligible for services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion for certain centers from fee for service to prepaid operations and change the governing board requirements for public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This document extends the comment period for a proposed rule that generally would revise the hospital conditions of participation under Medicare and Medicaid, published in the Federal Register (62 FR 66726) on December 19, 1997. The comment period is extended 60 days for all provisions except the proposed new requirements relating to interactions between hospitals and organ procurement organizations, which are extended for an additional 14 days.     

Treatment of certain hospital services; proposed rulemaking--Internal Revenue Service. Notice of proposed rulemaking

This document contains proposed regulations relating to the treatment of certain hospital services furnished by a tax exempt hospital to other such hospitals. Changes to the applicable tax law were made by the Tax Reform Act of 1978. The proposed regulations would affect those tax exempt hospitals that furnish the services and would provide the furnishing hospitals with the guidance needed to determine their unrelated business taxable income.     

Availability of information and records to the public; fees for providing information and records; procedures and appeals--SSA. Notice of proposed rulemaking

The Social Security Administration (SSA) announces proposed changes in the fees it charges for providing records from its files and record related services. These proposed changes will conform SSA's fee schedule to that recently published by the Department of Health and Human Services (HHS). The proposed rules also implement the discretion given the Secretary of Health and Human Services by section 2207 of the Omnibus Budget Reconciliation Act of 1981 to charge the full cost of providing certain information and records. The proposed rules do not change SSA's longstanding policy of generally not charging an individual for information needed to assure that our records concerning her or him are correct. In preparing these amendments, we deleted from SSA's rules several provisions concerning Medicare information. The Health Care Financing Administration (HCFA) has published separate regulations governing the availability of Medicare information and records. We have also clarified the rules for handling requests for information about individuals under the Privacy Act and the Freedom of Information Act (FOIA) and incorporated HHS' recent rules on who has authority to release or deny records in this revised material.     

Projects grants for community health services; proposed rulemaking--Public Health Service. Notice of proposed rulemaking

The Assistant Secretary for Health with the approval of the Secretary of Health and Human Services proposes to revise the regulations governing the Community Health Centers grant program. The Health Services and Centers Amendments of 1978 made a number of changes in the statutory requirements governing the operation of the centers. The Amendments, among other things, change pharmacy services from supplemental to primary health services, establish priority for certain supplemental health services, provide an incentive for maximized collection of fees, permit conversion of certain centers from fee for service to prepaid operations, and change the governing board requirements or public centers. The proposed revisions are intended to revise the present regulations consistent with the revised statutory provisions.     

Deep discount industrial development bonds; proposed rulemaking--Internal Revenue Service, Treasury. Notice of proposed rulemaking

This document contains proposed regulations relating to the determination of the amount of proceeds of issues of industrial development bonds sold by the issuer at a substantial discount. This amount is used in determining whether "substantially all" of the bond proceeds are used for an "exempt purpose", i.e. those described in section 103(b) (4), (5), (6), or (7) of the Internal Revenue Code, and for purposes of the "major portion" test in section 103(b)(2). The regulations would affect issuers, holders, and recipients of the proceeds of industrial development bonds of the type described above.     

Medical care collection or recovery--VA. Notice

In a companion document published in the "Proposed Rules" section of this issue of the Federal Register, we proposed to amend VA's medical regulations concerning collection or recovery by VA for medical care or services provided or furnished to a veteran: (i) For a non-service connected disability for which the veteran is entitled to care (or the payment of expenses of care) under a health-plan contract; (ii) For a non-service connected disability incurred incident to the veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or (iii) For a non-service connected disability incurred as a result of a motor vehicle accident in a State that requires automobile accident reparations insurance. The proposed rule includes methodology for establishing charges for VA medical care or services. Using this methodology, information for calculating proposed charge amounts at individual VA facilities for inpatient facility charges, skilled nursing facility/sub-acute inpatient facility charges, outpatient facility charges, and physician charges is set forth below. If this methodology were adopted subsequently as a final rule, the applicable data in this document, designed for the period August 1998 through September 1999, would be used for the period from the effective date of the final rule through September 1999. Accordingly, interested parties may wish to retain this document for future reference.     

Respiratory protective devices--NIOSH. Notice of proposed rulemaking

This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modulates which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate-filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air-purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule.     

NIH center grants--PHS. Notice of proposed rulemaking

This Notice sets forth proposed regulations covering grants by the National Institutes of Health for the support of research and demonstration centers. These regulations would replace existing regulations covering just centers supported by the National Heart, Lung, and Blood Institute.     

Privacy Act of 1974; exempt record system--DHHS. Notice of proposed rulemaking

The Assistant Secretary for Personnel Administration, through the Office of Personnel systems Integrity of the Department of Health and Human Services, by separate Federal Register notice is proposing alteration in the system of records entitled. "Management Information System Efficiency Report (MISER), HHS/OS/ASPER/OPSI", 09-90-0095. The Department intends to exempt portions of this system from certain provisions of the Privacy Act, 5 U.S.C. 552a. The proposed exemption is authorized by subsection (k)(2) of the Privacy ect, which applies to investigative materials compiled for law enforcement purposes. The Offices of Personnel Systems Integrity (OPSI) is authorised to gather information for personnel, legal and regulatory enforcement purposes under Title 5 U.S.C., Chapter 12. In order to maintain the integrity of the OPSI process of merit system and prohibited personnel practice complaints investigations, and to ensure that the Office of Personnel Systems Integrity will be able to obtain access to complete and accurate information, the Department proposes to exempt from the notification, access, correction, and amendment provisions of the Privacy Act those portions of Management Information System Efficiency Report (MISER) which contain personal information that would identify either a confidential source or an individual other than the complainant or subject of an investigation.     

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.     

Nursing student loan program--PHS. Notice of proposed rulemaking

This proposed rule would revise existing regulations governing the Nursing Student Loan (NSL) program. These revisions would impose more detailed requirements concerning the exercise of due diligence by schools in loan collections.