Department of Health and Human Services May 2008 – Federal Register Recent Federal Regulation Documents
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Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System
The Food and Drug Administration (FDA) is proposing to reclassify the full field digital mammography (FFDM) system from class III (premarket approval) to class II (special controls). The device type is intended to produce full field digital x-ray images of the breast. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System'' that would serve as the special control for the device, if FDA reclassifies this device type.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System.'' This draft guidance document describes a means by which the full field digital mammography (FFDM) system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the FFDM system device type from class III (premarket approval) into class II (special controls). This draft guidance is neither final nor is it in effect at this time.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice announces a hospital's request for a waiver from entering into an agreement with its designated Organ Procurement Organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The draft guidance was developed as the special controls to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This draft guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify PTCA catheters, other than cutting/scoring PTCA catheters, from class III to class II. This draft guidance is not final nor is it in effect at this time.
Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters
The Food and Drug Administration (FDA) is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) to class II (special controls). The Panel made this recommendation after reviewing the reclassification petition submitted by Cook Group Inc. (COOK) and other publicly available information. FDA is also announcing for public comment its tentative findings based on the Panel's recommendation and other publicly available information. After considering any public comments on the Panel's recommendation and FDA's tentative findings, FDA will approve or deny the reclassification petition by order in the form of a letter to the petitioner. FDA's decision on the reclassification petition will be announced in the Federal Register. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.
General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device
The Food and Drug Administration (FDA) is reclassifying the device type, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin'' that will serve as the special control for the reclassified device type.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesive for the topical approximation of skin may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to reclassify these device types from class III into class II (special controls).
Notice of Hearing: Reconsideration of Disapproval of Texas State Plan Amendment (SPA) 07-020
This notice announces an administrative hearing to be held on July 8, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Suite 833, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Texas SPA 07-020. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by June 13, 2008.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUCENTIS
The Food and Drug Administration (FDA) has determined the regulatory review period for LUCENTIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.
Privacy Act of 1974; Report of a Modified or Altered System of Records
The Privacy Act of 1974 and section 1106 of the Social Security Act (the Act) explain when and how CMS may use and disclose the personal data of people with Medicare. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173) added requirements for releasing and using personal data. To meet these additional requirements, CMS proposes to modify the existing system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09-70-0553, established at 70 FR 58436 (October 6, 2005). Under this modification we are clarifying the statutory authorities for which these data are collected and disclosed. The original SOR notice cited the statutory section governing CMS's payment of Part D plan sponsors (Social Security Act Sec. 1860D-15) that limits the uses of the data collected to purposes related to plan payment and oversight of plan payment. However, the broad authority of Sec. 1860D-12(b)(3)(D) authorizes CMS to collect, use and disclose Part D data for broader purposes related to CMS's responsibilities for program administration and research. Furthermore the authority under Sec. 1106 of the Act allows the Secretary to use and disclose data pursuant to a regulation, which in this case would be 42 CFR 423.505. CMS has published a final rule in order to clarify our statutory authority and explain how we propose to implement the broad authority of Sec. 1860D-12(b)(3)(D) and 1106 of the Act. This SOR is being revised to reflect our intended use of this broader statutory authority. In addition to updating this SOR to reflect our broader statutory authority, CMS proposes to make the following modifications to the DDPS system: Revise published routine use number 1 to include CMS grantees that perform a task for the agency. Add a new routine use number 2 to allow the use and disclosure of information to other Federal and state agencies for accurate payment of Medicare benefits; to fulfill a requirement or allowance of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and to help Federal/state Medicaid programs that may need information from this system. Broaden the scope of routine use number 4 to allow the use and disclosure of specified data as described in CMS's Part D data final rule, 42 CFR 423.505(m) to other government agencies, States or external organizations, in accordance with the minimum data necessary policy and Federal law. Delete published routine use number 5 which authorizes disclosure to support constituent requests made to a congressional representative. Broaden the scope of routine use number 7 and 8, to include combating ``waste,'' in addition to fraud and abuse that result in unnecessary cost to federally-funded health benefit programs. Revise language regarding routine uses disclosures to explain the purpose of the routine use and make clear CMS's intention to use and disclose personal information contained in this system. Reorder and prioritize the routine uses. Update any sections of the system affected by the reorganization or revision of routine uses because of MMA provisions or regulations promulgated based on MMA provisions. Update language in the administrative sections to be consistent with language used in other CMS SORs. The primary purpose of this system is to collect, maintain, and process information on all Medicare covered, and as many non-covered drug events as possible, for people with Medicare who have enrolled into a Medicare Part D plan. The system helps CMS determine appropriate payment of covered drugs. It will also provide for processing, storing, and maintaining drug transaction data in a large-scale database, while putting data into data marts to support payment analysis. CMS would allow the expanded use and disclosure of information in this system to: (1) Support regulatory, analysis, oversight, reimbursement, operational, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee; (2) support another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist Medicare Part D sponsors; (4) support an individual or organization with projects that provide transparency in health care on a broad-scale enabling consumers to compare the quality and price of health care services for a research, evaluation, or epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or for payment related purposes; (5) assist Quality Improvement Organizations; (6) support lawsuits involving the agency; and (7) combat fraud, waste, and abuse in certain Federally funded health benefits programs.
Proposed Collection; Comment Request; The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Prevalence and Incidence of HIV Molecular Variants and Their Correlation With Risk Behaviors and HIV Treatment in Brazilian Blood Donors. Type of Information Collection Request: NEW. Need and Use of Information Collection: Establishing and monitoring viral prevalence and incidence rates, and identifying risk behaviors for HIV incidence among blood donors, are critical to assessing and reducing risk of HIV transmission through blood transfusion. Identifying donation samples from donors with recent HIV infection is particularly critical as it enables characterization of the viral subtypes currently transmitted within the screened population and hence most likely to ``break-through'' routine screening measures (i.e., peri-seroconversion window period donations). Molecular surveillance of incident HIV infections in blood donors not only characterizes genotypes of recently infected donors for purposes of blood safety, but also enables documentation of the rates of primary transmission of anti-viral drug resistant strains in the community, serving a public health role in identifying new HIV infections for anti-retroviral treatment. Both a prospective surveillance and a case- control design are proposed to enroll all eligible HIV seropositives detected at three blood centers in Brazil (S[atilde]o Paulo, Belo Horizante, and Rec[iacute]fe) plus a satellite center in Rio de Janeiro. A comparison of epidemiological risk profiles will be made between the seropositive donors and a group of randomly selected seronegative donors. There are three study aims. Laboratory studies (LS-EIA testing and sequencing of pol region) on linked specimens from all enrolled HIV cases, will allow for estimation of HIV prevalence and incidence relative to genotype and putative route of infection. Data derived from molecular genotyping, including drug resistant genotypes, will be provided, along with counseling, to all enrolled HIV positive donors to facilitate their clinical care via referral to the Brazilian national HIV treatment system. Our findings will be compared to trends in prevalence, incidence and molecular variants from studies of the general population and high risk populations in Brazil, thus allowing for broad monitoring of the HIV epidemic in Brazil and assessment of the impact of donor selection criteria on these parameters. Finally, HIV cases and a group of controls, through responses to a questionnaire, will provide data on HIV risk behaviors among prospective blood donors. This HIV risk behavior data will be used as covariates in the molecular surveillance analyses described above, as well as aid in assessing whether modifications may be needed to Brazil's routine blood center operational donor screening questionnaire. The study participants will return to their local blood center for the administration of an informed consent form, explaining the confidential nature of the research study as well as the risks and benefits to their participation. Once enrolled, they will be asked to complete the self-administered risk factor questionnaire. In addition, a small blood sample will be collected from each HIV seropositive participant to be used for the genotyping and drug resistance testing. The results of the drug resistance testing will be communicated back to the seropositive participants during an in-person counseling session at the blood center. Defining prevalence and incidence in blood donors and residual risk of HIV transmission by transfusions may lead to new regulations and blood safety initiatives in Brazil. The data can be used to project the yield, safety impact and cost effectiveness of implementing enhanced testing strategies such as combination antigen- antibody assays and/or NAT. Determination of HIV risk factors in donors (first time versus repeat donor status; volunteer versus replacement status; demographics and risk behaviors) will support policy discussions over strategies to recruit the safest possible donors in Brazil. The findings from this project will also complement similar monitoring of HIV prevalence, incidence, transfusion risk and molecular variants in the U.S. and other funded international REDS-II sites, thus allowing direct comparisons of these parameters on a global level. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 2,000; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.40 (including administration of the informed consent form and questionnaire completion instructions); and Estimated Total Annual Burden Hours Requested: 800. The annualized cost to respondents is estimated at: $5,200 (based on $6.50 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
The Food and Drug Administration (FDA) is proposing to amend its regulations concerning the format and content of the ``Pregnancy'', ``Labor and delivery'', and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The agency is proposing to require that labeling include a summary of the risks of using a drug during pregnancy and lactation and a discussion of the data supporting that summary. The labeling would also include relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation. The proposal would eliminate the current pregnancy categories A, B, C, D, and X. The ``Labor and delivery'' subsection would be eliminated because information on labor and delivery is included in the proposed ``Pregnancy'' subsection. The proposed rule is intended to create a consistent format for providing information about the effects of a drug on pregnancy and lactation that will be useful for decisionmaking by women of childbearing age and their health care providers.
Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices; Request for Comments
The Food and Drug Administration (FDA) is requesting comments on whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies (i.e. cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). FDA is specifically interested in understanding how breast cancer ablation feasibility trials can be constructed so that there exists standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens. The agency seeks to facilitate its understanding of local treatment for breast cancer using thermal ablation devices.
Medicare Program; Medicare Part D Claims Data
This final rule allows the Secretary to collect claims data that are presently being collected for Part D payment purposes for other research, analysis, reporting, and public health functions. The Secretary needs to use these data because other publicly available data are not, in and of themselves, sufficient for the studies and operations that the Secretary needs to undertake as part of the Department of Health and Human Service's obligation to oversee the Medicare program, protect the public's health, and respond to Congressional mandates. These data will also be used to better identify, evaluate and measure the effects of the Medicare Modernization Act of 2003, (MMA).
Food Labeling: Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on noncariogenic carbohydrate sweeteners and dental caries, i.e., tooth decay, to include isomaltulose as a substance eligible for the health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.
Medicare and Medicaid Programs; Hospice Conditions of Participation Extension of Timeline for Publication of Final Rule
This notice announces an extension of the timeline for publication of the ``Medicare and Medicaid Programs; Hospice Conditions of Participation'' final rule. This notice is issued in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act) which requires notice be provided in the Federal Register if a final regulation, due to exceptional circumstances, will take longer to publish than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and scope of comments warrants the extension of the timeline for publication.
The National Institute of Dental and Craniofacial Research Announces Plans To Develop Its Strategic Plan for 2009-2013 and Invites Public Comments
The NIDCR is developing a new strategic plan to guide the Institute's research efforts over the next five years (2009-2013). NIDCR is inviting public comments and input for the development of the plan via its Web site https://www.nidcr.nih.gov, by mail or fax to the addresses below.
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 16th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
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