Department of Health and Human Services May 2008 – Federal Register Recent Federal Regulation Documents

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 Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document entitled ``Class II Special Controls Guidance Document: Full Field Digital Mammography System'' that would serve as the special control for the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.

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.

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 Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance document that FDA intends will serve as the special control for this device type, if it is reclassified.

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).

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.

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.

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.

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.

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.

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).

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.

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.).

This notice announces the 27th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 27th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 18th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing a delay in the implementation of the Reportable Food Registry (the Registry) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDA intends to implement the FDAAA requirement to establish an electronic portal for reportable food by utilizing the business enterprise system currently under development by the agency. This system will be easy to use and the most efficient and cost effective for both users and the agency. FDA expects that the agency's business enterprise system will be operational in spring 2009. FDA acknowledges that the prohibited act provisions relating to the Registry will not apply until such time as FDA establishes the electronic portal to implement the Registry. In conjunction with this delay announcement, FDA is requesting comments on certain aspects of the Registry provisions.

In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

In this notice, we reapprove and grant AABB (formerly known as the American Association of Blood Banks) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) accreditation program and the Immunohematology Reference Laboratory (IRL) Program.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products'' dated May 2008. The draft guidance document is intended to provide recommendations to manufacturers, sponsors, and clinical investigators involved in the transplantation of allogeneic pancreatic islet cell products for clinical investigations of the treatment of type 1 diabetes mellitus. The draft guidance is intended to provide assistance by identifying the types of data and information obtained during investigational new drug studies that may be helpful in establishing the safety, purity, and potency of a biological product in a biologics license application (BLA).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of food industry supervisory employees about their awareness and perceptions of FDA's Food Defense Awareness Initiative ALERT.

Notice is hereby given that the Office of Resettlement, Division of Community Resettlement, will award supplemental funds without competition to nine agencies: Church World Service, Ethiopian Community Development Council, Episcopal Migration Ministries, Hebrew Immigrant Aid Society, International Rescue Committee, Lutheran Immigration and Refugee Services, the United States Committee for Refugees and Immigrants, the United States Conference of Catholic Bishops, and World Relief Corporation. The cost for these supplemental awards is $2.17 million. The Voluntary Agency Matching Grant program was created by Congress in 1979. Matching Grant services enable the Voluntary Agencies' resettlement agencies to work with recently arrived refugees and other eligible clients. The goal of the program is to assist refugees become economically self-sufficient without accessing public assistance within 120-180 days. Last year, 81% of clients entering the program were economically self-sufficient within 180 days. Since the Presidential Determination was signed in October 2007, the ceiling for refugees was raised from 70,000 to 80,000 to accommodate 10,000 additional Iraqi refugees. In addition, legislation passed in December 2007 and January 2008 created a new class of individuals eligible for the refugee services. Thousands of Afghani and Iraqi interpreters who served the U.S. military have been provided ``Special Immigrant Visas'' (SIV) and are now eligible for six or eight months of refugee services. The Matching Grant program is often the program of choice for these special populations as it is geared for readily employable cases and for SIV cases, conforms to the legislative time limits.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc)'' dated May 2008. The draft guidance document provides recommendations to establishments that collect human blood or blood components for a requalification method or process to reenter deferred donors into a donor pool based on a determination that the previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with Hepatitis B virus (HBV).

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.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). The USPSTF, a standing, independent panel of outside experts that makes evidence-based recommendations regarding the provision of clinical preventive services, is composed of members appointed to serve for four year terms with an option for reappointment. New members are selected each year to replace approximately one fourth of the USPSTF members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. USPSTF members meet three times a year for two days in the Washington, DC area. Between meetings, member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self nominate. Organizations and individuals may nominate one or more persons qualified for membership on the USPSTF. Qualification Requirements: The mission of the USPSTF is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the USPSTF, an applicant or nominee must demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Consideration will be given to individuals who are recognized nationally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the USPSTF including financial, intellectual, or other conflicts.

Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; Pub. L. 110-85) mandates the expansion of the existing ClinicalTrials.gov registry and the establishment of a clinical trial results database. This notice announces our intent to implement the expanded registry and the basic results database via rulemaking and to post for public comment on the website identified below preliminary materials related to the basic results database. Comments received on the preliminary basic results materials will be considered in the development of an operational version of the basic results database and in the drafting of the associated regulation and any necessary guidance documents. The regulation will be subject to a separate public comment process.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' This guidance document describes a means by which antigen detection assays for Plasmodium species may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for antigen detection assays for Plasmodium species, but it remains subject to comment in accordance with the agency's good guidance practices.

The NTP announces the availability of the draft background document for styrene on May 22, 2008, on the RoC Web site (https:// ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for styrene. The expert panel will meet on July 21-22, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 to peer review the draft background document for styrene and, once completed, make a recommendation regarding the listing status for styrene (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background document and the expert-panel peer review report on the RoC Web site.

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel on March 4-6, 2008 to evaluate new versions and applications of the LLNA for assessing the allergic contact dermatitis potential of chemicals and products. The peer review panel (``the Panel'') report from this meeting is now available. The report contains (1) the Panel's evaluation of the validation status of the methods and (2) the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/llnaPeerPanel.htm or by contacting NICEATM at the address given below.

This document corrects a technical error that appeared in the Notice of Proposed Rulemaking (NPRM) on April 17, 2008, entitled ``Organizational Integrity of Entities Implementing Leadership Act Programs and Activities.''

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS or the Department) is issuing in the third quarter of FY 2008 a Funding Opportunity Announcement (FOA) for the HPP, authorized under section 319C-2 of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417). The Consolidated Appropriations Act, 2008, provides funding for these awards (Pub. L. 110-161). This Federal Register notice provides information concerning critical aspects of this program including:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This proposed rule would make revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D). The regulation contains new regulatory provisions regarding special needs plans, medical savings accounts (MSA) plans, and cost- sharing for dual eligible enrollees in the MA program, the prescription drug payment and novation processes in the Part D program, and the enrollment, appeals, and marketing processes for both programs. We are proposing these changes based on lessons learned since 2006, the initial year of the prescription drug program and the revised MA program.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of June 25, 2007 (72 FR 34752). The final rule established current good manufacturing practice (CGMP) requirements in manufacturing, packaging, labeling, or holding operations for dietary supplements. The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to improve the accuracy of the agency's regulations.

The Food and Drug Administration (FDA) has determined the regulatory review period for ZOLINZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Conference Report (H.R. Rep. No. 110-107) accompanying the Consolidated Appropriations Act 2008 (Pub. L. 110-161), Division G Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2008, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2008 competition to current Healthy Start grantees. Senate Report 110-107 urges ``HRSA to give preference to current and former grantees with expiring or recently expired project periods.''

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.