Medicare program; establishment of the Medicare Advantage Program; interpretation. Final rule; interpretation

This final rule clarifies our interpretation of the meaning of "entity" in the final rule titled "Medicare Program; Establishment of the Medicare Advantage Program" published in the Federal Register on January 28, 2005 (70 FR 4588). Subsequent to the publication of the Medicare Advantage (MA) final rule on January 28, 2005, we have received inquiries from parties interested in offering an MA Regional Plan concerning whether they could jointly enter into a contract with us to offer a single MA Regional Plan in a multistate region. The participating health plans wish to contract with each other to create a single "joint enterprise." They have asked us whether such a joint enterprise could be considered an "entity" under sections 1859(a)(1)and 1855(a)(1) of the Social Security Act, for purposes of offering an MA Regional Plan. The MA final rule is scheduled to take effect on March 22, 2005. Our interpretation of the word "entity" that follows in the "Supplementary Information" section of this final rule is deemed to be included in that final rule.     

Medicare Program; OBRA '87 conforming amendments; correction--HCFA. Final rule; correction

Federal Register document No. 91-4415, beginning on page 8832 of the issue of Friday March 1, 1991, conformed numerous sections of the HCFA regulations with self-executing provisions of the Omnibus Budget Reconciliation Act of 1987. A one-page revision, dealing with the application of the Medicare blood deductible, was unintentionally omitted from column 2 of page 8852, where only the heading "P. Part 489" appears. Also omitted was a conforming change needed in section 482.12(c)(1)(iv) to reflect the amendment made by section 9336(a) of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99-509). Section 9336(a) removed the provision that limited Medicare coverage of optometrist services to aphakia. This means that any optometrist services permitted by State medical practice laws are now covered. This notice corrects the omissions by publishing the amendment to part 489, which was discussed in section "D" of the preamble in the first column of page 8834, and including the revision of section 482.12(e)(1)(iv). The notice also makes numerous other minor corrections.     

Quality mammography standards; correcting amendment--FDA. Final rule; correcting amendment

The Food and Drug Administration (FDA) is correcting its regulations governing mammography, published in a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The regulations are effective April 28, 1999; except section 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which become effective October 28, 2002. The October 28, 1997, document was published with some inadvertent typographical errors. Some of those errors were corrected in a document entitled "Quality Mammography Standards; Correction" that appeared in the Federal Register of November 10, 1997, but additional typographical errors occurred in the publication of this document. In addition, since November 10, 1997, certain other problems with the text of the regulations have been identified that, if uncorrected, would lead to unforeseen and undesirable consequences. This document corrects those errors.     

Natural rubber-containing medical devices; user labeling; cold seal adhesives partial stay--FDA. Final rule

The final rule for user labeling requirements for natural rubber-containing medical devices, 21 CFR 801-437, was published on September 30, 1997, and becomes effective on September 30, 1998. The Food and Drug Administration (FDA) is adding a note to that rule to stay, for 270 days from the effective date, paragraphs (f) and (g) as those final rule requirements relate to device packaging that uses "cold seal" adhesives. Labeling changes required by other paragraphs of this final rule must be incorporated in the labeling of devices distributed after September 30, 1998, even if the devices are packaged in "cold seal" packages. Device packaging that uses natural rubber only on adhesives contained in the flaps of device packaging is not considered subject to the rule. Manufacturers of devices packaged with "cold seal" adhesives may, if necessary, submit a petition for an extension of the 270-day stay.     

Quality mammography standards; correction--FDA. Final rule; correction

The Food and Drug Administration (FDA) is correcting a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The document was published with some inadvertent typographical errors and incorrect dates in the regulatory text. This document corrects those errors. FDA is also identifying with greater specificity those sections of the quality standards that will become effective October 28, 2002. For the convenience of the reader, FDA is republishing 21 CFR part 900 in its entirety with corrections.     

International Conference on Harmonisation; evaluation of stability data; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1E Evaluation of Stability Data." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products," which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717). It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product.     

Medical devices; radiology devices; reclassification of bone sonometers. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify bone sonometer devices from class III into class II, subject to special controls. FDA is taking this action on its own initiative after reviewing recent scientific and technological studies regarding bone sonometer devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers" that will serve as the special control for these devices.     

Medical devices; apnea monitor; special controls. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to create a separate classification for the apnea monitor. The device currently is included in the generic type of device called breathing frequency monitors. The apnea monitor will remain in class II, but will be subject to a special control. The special control is an FDA guidance document that identifies minimum performance, testing, and labeling recommendations for the device. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a "new" apnea monitor will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control. FDA is taking these actions because it believes that they are necessary to provide reasonable assurance of the safety and effectiveness of the apnea monitor.     

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.     

Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration; correction--FDA. Tentative final rule; correction

The Food and Drug Administration (FDA) is correcting a tentative final rule that appeared in the Federal Register of November 26, 1991 (56 FR 60024). The tentative final rule was published with some editorial errors. In the preamble under the "Paperwork Reduction Act" heading, the last two lines in the table "Estimated Annual Burden for Reporting" should have been in the table "Annual Burden for Recordkeeping". As a result, the total figures in both tables were incorrect. This document corrects the errors in these two tables.     

Medicaid program; multiple source drug definition. Final rule

This final rule revises the definition of "multiple source drug" to better conform the regulatory definition to the provisions of section 1927(k)(7) of the Social Security Act. It also responds to public comments received on the March 14, 2008 interim final rule with comment period.     

Foods--adulteration involving hard or sharp foreign objects; compliance policy guide; availability. Food and Drug Administration, HHS. Notice

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) entitled "Foods--Adulteration Involving Hard or Sharp Foreign Objects." This CPG is intended to help FDA components and industry comply with FDA's internal enforcement process concerning foods that contain hard or sharp foreign objects.     

International Conference on Harmonisation; guidance on M4 common technical document; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of guidance entitled "M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use" (M4CTD). The guidance was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is being made available simultaneously in four parts (general organization, quality, safety, and efficacy), describes a harmonized format for new product applications (including applications for biotechnology-derived products) for submission to the regulatory authorities in the three ICH regions. The M4 CTD is intended to reduce the time and resources used to compile applications, ease the preparation of electronic submissions, facilitate regulatory reviews and communication with the applicant, and simplify the exchange of regulatory information among regulatory authorities.     

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.     

Privacy Act of 1974; report of new system--HCFA. Notice of new system of records

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records, called the "National Provider System (NPS)," HHS/HCFA/OIS No. 09-70-0008. We have provided background information about the proposed system in the "Supplementary Information" section below. Both institutional (e.g., hospitals, skilled nursing facilitaties) and individually identifiable (e.g., physicians and other practitioners) providers are included in the NPS database. The institutional providers' data are covered by section 1106 of the Social Security Act and the Freedom of Information Act, while the individually identifiable providers' data are also covered by the Privacy Act of 1974. Although the Privacy Act requires only that the "routine uses" portion of the system be published for comment, HCFA invites comments on all portions of this notice. See "Effective Dates" for comment period.     

Microbiology devices; reclassification of hepatitis A virus serological assays. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify hepatitis A virus (HAV) serological assays from class III (premarket approval) into class II (special controls). FDA is taking this action after reviewing a reclassification petition submitted by Beckman Coulter, Inc. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays" that will serve as the class II special control for these devices.