Department of Health and Human Services June 2011 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of June 20, 2011 (FR Doc. 2011-15194), on page 35900, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is announcing the opening of a docket to solicit comments, data, and other information helpful to assess the current research, policy, and practice environment in public health genomics. HHS/CDC is currently leading a process to assess the most important steps for public health genomics in the next five years.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component 2012-2013.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

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 Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study and federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment. Proposed Collection: Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS). Type of Information Collection Request: Generic Clearance. Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes approaches to developing process and drug substance understanding and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The draft guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions.

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 Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source cooperative agreement with the World Health Organization (WHO). The goal of the Food and Drug Administration, Office of the Commissioner and the Office of International Programs, Center for Food Safety and Nutrition, and the Center for Veterinary Medicine is to contribute to the knowledge base of the current state of food safety globally, including challenges, risks and emerging trends, through an integrated information system based on WHO's existing network efforts.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement for the National Alliance for Hispanic Health. The goal of the Food and Drug Administration, Office of the Commissioner, is to support initiatives that will communicate risk and emergency public health information to millions of Spanish-speaking consumers within the targeted populations (socially disadvantaged, underserved populations, ethnic and racial populations, health professionals, patients and caregivers, pediatrics, adolescents, and disabled and older Americans).

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed two petitions proposing that the color additive regulations be amended to provide for the safe use of 1,4- bis[4-(2-methacryloxyethyl)phenlyamino] anthraquinone (C.I. Reactive Blue 246) and 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additives are intended to be copolymerized with various monomers for use as colored contact lens materials.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 22, 2011 (76 FR 22714) and allowed 60-days for public comment. One public comment was received on April 23, 2011 which commented on the number of previous surveys and expense. An e-mail response was sent on April 25, 2011, stating, ``Thank you for your comments. We will take your comments into consideration.'' The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Health Information National Trends Survey 4 (HINTS 4) (NCI) (OMB 0925-0538, Exp 11/30/2008). Type of Information Collection Request: Reinstatement with Change. Need and Use of Information Collection: HINTS 4 will provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer across the cancer care continuum from cancer prevention, early detection, diagnosis, treatment, and survivorship. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained, and assessment of cancer-related behavior. The Public Health Services Act, Sections 411 (42 U.S.C. 285a) and 412 (42 U.S.C. 285a-1.1 and 285a-1.3), outline the research and information dissemination mission of the NCI which authorizes the collection of this information. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 18+). The annual reporting burden is documented in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined the regulatory review period for XYZAL 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.

This notice announces the second semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2011. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the final rule that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2012.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), will hold a public forum from July 11-13, 2011 on processes relating to community health needs assessment (CHNA) and implementation strategy/plan development and execution. HHS/CDC is developing best practices designed to support state and local health departments to meet public health accreditation standards, and by other entities who may wish to utilize them in their community health planning processes. This notice announces the public forum.

HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located at 110 Hopkins Street, Buffalo, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

HHS gives notice of a determination concerning a petition to add a class of employees from the Wah Chang facility in Albany, Oregon, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

HHS gives notice of a determination concerning a petition to add a class of employees from the Linde Ceramics Plant in Tonawanda, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed Consent.'' This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): Dissolution Test General Chapter'' (Q4B Annex 7(R2)). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Q4B Annex 7(R2) is a revision of the previously published ICH guidance, ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions, updates the considerations for implementation, and updates the references used for the Q4B evaluation. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Pharmacogenomic Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Timothy J. Rosio, M.D. for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Rosio was convicted of misdemeanors under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Rosio was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Rosio failed to respond. Dr. Rosio's failure to respond constitutes a waiver of his right to a hearing concerning this action.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 18th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) has determined the regulatory review period for DEXILANT (previously KAPIDEX) 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 a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for Fusilev (Levoleucovorin) 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 Department of Health and Human Services released the 12th RoC to the public on June 10, 2011. The report is available on the RoC Web site at: https://ntp.niehs.nih.gov/go/roc12 or in printed text or electronically from the Office of the RoC (see ADDRESSES below).

On September 13, 2010, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) proposing changes to the regulations governing the National Vaccine Injury Compensation Program (VICP). Specifically, the Secretary proposed revisions to the Vaccine Injury Table (Table) to create distinct listings for hepatitis A, trivalent influenza, meningococcal, and human papillomavirus vaccines. The Secretary is now making this amendment to the Table by final rule; it is technical in nature. The four categories of vaccines described in this final rule are already covered vaccines under the VICP (starting in 2004) and are currently listed in a placeholder category (box XIII) in the Table. This final rule will list these vaccines as separate categories on the Table, with no associated injuries noted at this time, in order to help the public identify clearly that these vaccines are covered by the VICP. The changes implemented here are authorized by section 2114(e) of the Public Health Service Act (the Act).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Advertisements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and effectiveness of devices and reduce use error. This draft guidance is not final; nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to PregLem SA of an exclusive patent license to practice the inventions embodied in US Patent Application 12/021,610 entitled, ``Method for Treating Uterine Fibroids'' [HHS Ref. E-057-2008/0-US-01], and all continuing applications and foreign counterparts. The patent rights in this invention have been assigned to the Government of the United States of America and to Laboratoire HRA Pharma. The exclusive license contemplated in this notice is solely to the patent rights assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: The use of ulipristal acetate for the treatment of symptomatic uterine fibroids.

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 Food and Drug Administration (FDA) proposes to amend the sterility test requirements for biological products. This proposed rule is intended to provide manufacturers of biological products greater flexibility and to encourage use of the most appropriate and state-of- the-art test methods for assuring the safety of biological products. We are taking this action as part of our continuing effort to review and, as necessary, update the biologics regulations.

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 Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Radioactive Drug Research Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Healthy Communities Study: How Communities Shape Children's Health (HCS). Type of Information Collection Request: New. Need and Use of Information Collection: The HCS will address the need for a cross-cutting national study of community programs and policies and their relationship to childhood obesity. The HCS is an observational study of communities conducted over five years that aims to (1) Determine the associations between community programs/policies and Body Mass Index (BMI), diet, and physical activity in children; and (2) identify the community, family, and child factors that modify or mediate the associations between community programs/policies and BMI, diet, and physical activity in children. A total of 279 communities and over 23,000 children and their parents will be part of the HCS over the five-year study. A HCS community is defined as a high school catchment area and the age range of children is 3-15 years upon entry into the study. The study examines quantitative and qualitative information obtained from community-based initiatives; community characteristics (e.g., school environment); measurements of children's physical activity levels and dietary practices; and children's and parents' BMIs. Results from the Healthy Communities Study may influence the future development and funding of policies and programs to reduce childhood obesity. Furthermore, HCS results will be published in scientific journals and will be used for the development of future research initiatives targeting childhood obesity. Frequency of Response: Varies by participant type from once to 2.74 times. Affected Public: Families or households; businesses, other for-profit, and non-profit. Type of Respondents: Parents, children, community key informants (who have knowledge about community programs/ policies related to healthy nutrition, physical activity, and healthy weight of children), food service personnel, physical education instructors, state health department employees, and physicians or medical secretaries. The annual reporting burden is as follows: Estimated number of respondents: 247,619; Estimated Number of Responses per Respondent: 1.1; Average (Annual) Burden Hours per Response: 0.12; and Estimated Total Burden Hours Requested: 32,958. The annualized cost to respondents is estimated at $213,764.58. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 SPF labeling and testing requirements for over-the-counter (OTC) sunscreen products containing specified ingredients and marketed without approved applications, and on compliance with Drug Facts labeling requirements for all OTC sunscreen products.

We (Food and Drug Administration or FDA) are asking sunscreen manufacturers and other interested parties to submit data on over-the- counter (OTC) sunscreen drug products marketed without approved applications that are formulated in certain dosage forms. These data are necessary to address questions about these dosage forms. For spray dosage forms, we are requesting data to resolve specific questions about both effectiveness and safety. We are also inviting comment on possible labeling and testing requirements for spray dosage forms. This information will be used in establishing monograph conditions, including dosage forms, for sunscreens that are generally recognized as safe and effective (GRASE) and not misbranded.

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

The Indian Health Service published a document in the Federal Register on June 8, 2011, concerning competitive cooperative agreement applications to establish Tribal Epidemiology Centers serving American Indian/Alaska Native Tribes and urban Indian communities. The document contained one incorrect date.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based Devices.'' This draft guidance document provides industry and Agency staff with recommendations for studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of methicillin-resistant S. aureus (MRSA), including those for the detection or detection and differentiation of MRSA versus S. aureus (SA) in either human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time.

The National Biodefense Science Board's (NBSB) Anthrax Vaccine (AV) Working Group (WG) will hold a public engagement workshop on July 7, 2011, to discuss vaccine to protect children from anthrax. This meeting is open to the public and prior registration is required. The public may attend in-person or by teleconference.

This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the third of three notices which must be published over a 90-day period in order to advise the public of the agency's intention to sponsor an FFRDC.