Department of Health and Human Services April 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Consortium of Cardiovascular Registries.'' The purpose of this meeting is to discuss the development of an international consortium of cardiovascular registries with a broad array of interested stakeholders. The initial pilot phase of this effort will be developing relationships and analysis strategies for transcatheter cardiac valve registries, with the understanding that these efforts would be expanded to additional cardiovascular devices in the future. Date and Time: The meeting will be held on April 22, 2013, from 8 a.m. to 5 p.m. Location: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Benjamin Eloff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD 20993, 301-796-8528, Benjamin.eloff@fda.hhs.gov; or Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301-796- 6689, Danica.marinac-dabic@fda.hhs.gov. Registration: Registration is free and will be on a first-come, first-served basis. Persons interested in attending this public meeting must register online by 5 p.m. on April 11, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 7 a.m. To register for the public meeting, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm. Select this public meeting from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, mailing address, email address, and telephone number. Those without Internet access should contact Susan Monahan to register (Susan.Monahan@fda.hhs.gov or 301-796-5661). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. If you need special accommodations due to a disability, please contact Susan Monahan (Susan.Monahan@fda.hhs.gov or 301-796-5661) no later than April 11, 2013. Streaming Webcast of the Public Meeting: This meeting will also be available via Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on April 11, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after April 16, 2013. If you have never attended a Connect Pro event before, test your connection at https:// collaboration.fda.gov/common/help/en/support/meetingtest.htm. To get a quick overview of the Connect Pro program, visit https:// www.adobe.com/go/connectprooverview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public meeting to obtain information on the topics identified in section II. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. The deadline for submitting comments related to this public meeting is May 22, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting. Regardless of attendance at the public meeting, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. Transcripts: Transcripts will not be provided.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs).'' The purpose of this guidance document is to identify the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that do not have an associated user fee. The guidance also identifies industry and FDA actions on these submissions that may result in a refund of the fee. The draft of this document was issued on March 16, 2009.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Wednesday, February 27, 2013 (78 FR 13347). The meeting was shortened to one day, as it was later determined that in order to be more financially prudent all three topics could fit into one day.

The Food and Drug Administration (FDA) is announcing that we have concluded that certain statements set forth in the FDA-approved labels of over-the-counter nicotine replacement therapy products, related to concomitant use with other nicotine-containing products and duration of use, can be modified. In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the- counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation. We encourage the submission of supplemental new drug applications (labeling supplements) to modify these statements as described in this notice.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: Bureau of Health Professions Performance Data Collection (OMB No. 0915-0061)[Revision]. Abstract: Over 40 BHPr programs award grants to health professions schools and training programs across the United States to develop, expand, and enhance training; and to strengthen the distribution of the health workforce. Many of these programs are governed by the Public Health Service Act (42 U.S.C. 201 et seq.), specifically Titles III, VII, and VIII. Performance information is collected in the HRSA Performance Report for Grants and Cooperative Agreements (PRGCA). Data collection activities at application, progress, and annual performance satisfy statutory and programmatic requirements for performance measurement and evaluation (including specific Title III, VII and VIII requirements), as well as Government Performance and Results Act (GPRA) requirements. The Affordable Care Act (Pub. L. 111- 148) impacted a broad range of health workforce programs administered by BHPr. It reauthorized most of these programs and, in some cases, expanded eligibility, modified program activities, and/or established new requirements. The Affordable Care Act also created new health professions programs. Therefore, it was necessary to reexamine BHPr's existing performance measures to ensure that they address these changes, meet evolving program management needs, and respond to emerging workforce concerns. The proposed revised data collection will enhance analysis and reporting of grantee training and education activities, outcomes, and intended practice locations. Data collected from these grant programs will also provide a description of the program activities of more than 1,600 reporting grantees to better inform policymakers on the barriers, opportunities, and outcomes involved in health care workforce development. The proposed measures focus on five key outcomes: (1) Increasing the workforce supply of diverse well-educated practitioners; (2) influencing the distribution of practitioners to practice in underserved and rural areas; (3) enhancing the quality of education; (4) diversifying the pipeline for new health professionals; and (5) supporting educational infrastructure to increase the capacity to train more health professionals. Revisions to the current reporting will require the collection of baseline data at the grant application and award stages and will include performance reporting semi-annually by the type of programs: direct financial support programs, infrastructure programs, and multipurpose or hybrid programs (could be direct financial support, infrastructure or both within the same grant program). Measures will be reported at the individual, program-specific and/or program cluster-levels. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.

The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This revised draft document combines and supersedes ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA has now revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.

The National Toxicology Program (NTP) requests information on medium- or high-throughput technologies/assay systems, which allow for the batch screening of compounds (e.g., 25-50) in biochemical- or cell- based assays or alternative (non-rodent) animal models, that might be used to prioritize compounds for in vivo neurotoxicity testing.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses. This action is in response to two color additive petitions (CAPs) filed by CooperVision, Inc.