Administrative review process for adjudicating initial disability claims. Final rule

The Social Security Administration is committed to providing the high quality of service the American people expect and deserve. In light of the significant growth in the number of disability claims and the increased complexity of those claims, the need to make substantial changes in our disability determination process has become urgent. We are publishing a final rule that amends our administrative review process for applications for benefits that are based on whether you are disabled under title II of the Social Security Act (the Act), or applications for supplemental security income (SSI) payments that are based on whether you are disabled or blind under title XVI of the Act. We expect that this final rule will improve the accuracy, consistency, and timeliness of decision-making throughout the disability determination process.     

State systems Advance Planning Document (APD) process. Final rule

The Advance Planning Document (APD) process governs the procedure by which States obtain approval for Federal financial participation in the cost of acquiring automated data processing equipment and services. This final rule reduces the submission requirements for lower-risk information technology (IT) projects and procurements and increases oversight over higher-risk IT projects and procurements by making technical changes, conforming changes and substantive revisions in the documentation required to be submitted by States, counties, and territories for approval of their Information Technology plans and acquisition documents.     

Medicaid program; review and approval process for Section 1115 demonstrations. Final rule

This final rule will implement provisions of section 10201(i) of the Patient Protection and Affordable Care Act of 2010 that set forth transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children's Health Insurance Program (CHIP). This final rule will increase the degree to which information about Medicaid and CHIP demonstration applications and approved demonstration projects is publicly available and promote greater transparency in the review and approval of demonstrations. It will also codify existing statutory requirements pertaining to seeking advice from Indian health care providers and urban Indian organizations for section 1115 demonstration projects, and for the first time impose as regulatory requirements tribal consultation standards that were previously only published as guidance documents.     

Medical device reporting: manufacturer reporting, importer reporting, user facility reporting, distributor reporting. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing reporting by manufacturers, importers, distributors and health care (user) facilities of adverse events related to medical devices. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Occupational injury and illness recording and reporting requirements. Final rule

The Occupational Safety and Health Administration (OSHA) is delaying the effective date of three provisions of the Occupational Injury and Illness Recording and Reporting Requirements rule published January 19, 2001 (66 FR 5916-6135) and is establishing interim criteria for recording cases of work-related hearing loss. The provisions being delayed are sections 1904.10 (a) and (b), which specify recording criteria for cases involving occupational hearing loss, section 1904.12, which defines "musculoskeletal disorder (MSD)" and requires employers to check the MSD column on the OSHA Log if an employee experiences a work-related musculoskeletal disorder, and section 1904.29(b)(7)(vi), which states that MSDs are not considered privacy concern cases. The effective date of these provisions is delayed from January 1, 2002 until January 1, 2003. OSHA will continue to evaluate sections 1904.10 and 1904.12 over the next year. OSHA is also adding a new paragraph(c) to section 1904.10, establishing criteria for recording cases of work-related hearing loss during calendar year 2002. Section 1904.10(c) codifies the enforcement policy in effect since 1991, under which employers must record work related shifts in hearing of an average of 25 dB or more at 2000, 3000 and 4000 hertz in either ear.     

Occupational injury and illness recording and reporting requirements. Final rule

The Occupational Safety and Health Administration (OSHA) is revising the hearing loss recording provisions of the Occupational Injury and Illness Recording and Reporting Requirements rule published January 19, 2001 (66 FR 5916-6135), scheduled to take effect on January 1, 2003 (66 FR 52031-52034). This final rule revises the criteria for recording hearing loss cases in several ways, including requiring the recording of Standard Threshold Shifts (10 dB shifts in hearing acuity) that have resulted in a total 25 dB level of hearing above audiometric zero, averaged over the frequencies at 2000, 3000, and 4000 Hz, beginning in year 2003.     

State certification of mammography facilities. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.     

Recordkeeping and reporting under Title VII and the ADA--EEOC. Final rule

This final rule is based on two separate Notices of Proposed Rulemaking (NPRM) published on February 13, 1989 (54 FR 6551), and March 5, 1991 (56 FR 9185). This final rule amends 29 CFR part 1602, EEOC's regulations on Recordkeeping and Reporting under title VII of the Civil Rights Act of 1964 (title VII), to add recordkeeping requirements under the Americans with Disabilities Act of 1990 (ADA). It increases the records retention period required in part 1602 for title VII and the ADA from 6 months to one year. The Commission also is adding a new subpart R to part 1602, 29 CFR 1602.56, that will clarify that the Commission has the authority to investigate persons to determine whether they comply with the reporting or recordkeeping requirements of part 1602. In addition, the Commission is making several minor changes to sections 1602.7 and 1602.10. The Commission also is deleting section 1602.14(b) of its title VII recordkeeping regulations, which provides that the section 1602 recordkeeping requirements do not apply to temporary or seasonal positions. Information regarding such employees now must be reported on Standard Form 100 on September 30 of each year, in the same fashion as information regarding permanent employees is reported. Similarly, the Commission is deleting sections 1627.3(b) and 1627.4(a)(2) of the Age Discrimination in Employment Act recordkeeping regulations, which provide for a 90-day retention period for temporary positions, and is clarifying the mandatory nature of such recordkeeping. The Commission is not issuing a final rule on proposed section 1602.57 at this time.     

Medicare program; uniform electronic cost reporting system for hospitals--HCFA. Final rule

This final rule responds to comments on the May 25, 1994, final rule with comment period that implemented a standardized electronic cost reporting system for all hospitals under the Medicare program. In that rule, we solicited comments on the requirement that cost reporting software be able to detect changes made to the electronic file after the provider has submitted it to the fiscal intermediary. This final rule responds to comments on that requirement and clarifies that although changes to the "as-filed" electronic cost report are prohibited, an intermediary makes a working copy of the as-filed electronic cost report for use in the settlement process.     

Medicare program; reporting of interest from zero coupon bonds--HCFA. Final rule

This final rule requires Medicare providers to report all interest expense and interest income from zero coupon bonds in the cost reporting period in which the interest was accrued. This final rule is necessary to add provisions to the Medicare regulations that specifically address the reporting by providers of interest expense and income from zero coupon bonds.     

Assignment of agency component for review of premarket applications--FDA. Final rule

The Food and Drug Administration (FDA) is promulgating a new regulation to describe how the agency will determine which component within FDA will have primary jurisdiction for the premarket review and regulation of: (1) A combination drug, device, or biologic product or (2) any drug, device, or biologic product where the center with primary jurisdiction is unclear or in dispute. This rule describes how to identify the agency's assigned review component which will, in most cases, eliminate the need for a sponsor to obtain approval from more than one FDA component for a combination product.     

Amendments to the quick disability determination process. Final rule

We are amending our regulations to extend the quick disability determination process (QDD), which is operating now in the Boston region, to all of the State disability determination services (DDSs). We also are removing from the QDD process the existing requirements that each State DDS maintain a separate QDD unit and that each case referred under QDD be adjudicated within 20 days. These actions stem from our continuing effort to improve our disability adjudication process.     

Medicare program; electronic cost reporting for skilled nursing facilities and home health agencies--HCFA. Final rule

This final rule adds the requirement that, for cost reporting periods ending on or after February 1, 1997, most skilled nursing facilities and home health agencies must submit cost reports currently required under the Medicare regulations in a standardized electronic format. This rule also allows a delay or waiver of this requirement where implementation would result in financial hardship for a provider. The provisions of this rule allow for more accurate preparation and more efficient processing of cost reports.     

Expedited safety reporting requirements for human drug and biological products; correction--FDA. Final rule; correction

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of October 7, 1997 (62 FR 52237), to include some conforming amendments that were inadvertently omitted. The final rule amended the expedited safety reporting regulations for human drug and biological products. This action is being taken to ensure the accuracy and consistency of the regulations.     

Rate increase disclosure and review. Final rule with comment period

This final rule with comment period implements requirements for health insurance issuers regarding disclosure and review of unreasonable premium increases under section 2794 of the Public Health Service Act. The final rule establishes a rate review program to ensure that all rate increases that meet or exceed a specified threshold are reviewed by a State or CMS to determine whether they are unreasonable and that certain rate information be made public.     

Medicare program; uniform electronic cost reporting system for hospitals--HCFA. Final rule with comment period

This final rule with comment period implements the provisions of section 4007(b) of the Omnibus Budget Reconciliation Act of 1987, as amended by section 411(b)(6) of the Medicare Catastrophic Coverage Act of 1988, which require the Secretary to place into effect a standardized electronic cost reporting system for all hospitals under the Medicare program. Under this final rule with comment period, all hospitals are required to submit their cost reports, for hospital cost reporting periods beginning on or after October 1, 1989, in a uniform electronic format. The Secretary may grant a delay or a waiver of this requirement where implementation could result in financial hardship for a hospital.     

Biological products: reporting of biological product deviations in manufacturing. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the regulation requiring licensed manufacturers of biological products to report errors and accidents in manufacturing that may affect the safety, purity, or potency of a product. FDA also is amending the current good manufacturing practice (CGMP) regulations for blood and blood components to require establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered establishments and transfusion services, to report biological product deviations in manufacturing. The final rule requires licensed manufacturers, unlicensed registered blood establishments, and transfusion services who had control over the product when a deviation occurred to report to FDA the biological product deviation if the product has been distributed. The final rule also establishes a 45-day reporting period. FDA is issuing the final rule as part of a retrospective review under Executive Order 12866 of significant FDA regulations to improve the effectiveness of FDA's regulatory program.     

Medical devices; medical device distributor reporting; opportunity for comments--FDA. Final rule; opportunity for comments

The Food and Drug Administration (FDA) is announcing an opportunity for public comments on the final rule on medical device distributor reporting, which is published elsewhere in this issue of the Federal Register. The medical device distributor reporting tentative final rule became final on May 28, 1992, by operation of the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments). Although not required to do so, FDA realizes that there may be issues not previously considered, such as technical issues on specific provisions, and therefore is providing this additional time for comment. If changes are warranted by comments, FDA will make further changes in the rules.     

Recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB). Final rule

DEA is amending its regulations to require additional recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB) for which an application has been approved under the Federal Food, Drug, and Cosmetic Act. DEA makes these changes under section 4 of the "Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000." These additional requirements are necessary to protect against the diversion of GHB for illicit purposes.