Department of Health and Human Services April 9, 2014 – Federal Register Recent Federal Regulation Documents

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 Allergy and Infectious Diseases (NIAID), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Lyndi Lahl, RN, MS, Office for Policy in Clinical Research Operations, DAIDS, NIAID, 6700B Rockledge Drive, Room 4254, Bethesda, MD 20852, or call non-toll-free number 301-435-3756, or Email your request, including your address to: Lynda.Lahl@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Process Assessment Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS) Critical Events Policy Implementation (CEPI) Program, 0925-New, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: This is a new data collection to assess the CEPI program's progression to fulfillment of its program goals and will assess whether the CEPI program is implemented and functioning as intended. The program goals for CEPI are: (1) Awareness & AccessibilityThe target populations (DAIDS Staff, extramural researchers, external stakeholders) are aware of the DAIDS Critical Events (CE) policy and manual and associated documents and whether the policy and associated documents are readily accessible.; (2) UnderstandabilityThe Critical Events policy and manual clearly articulate DAIDS expectations for CE policy implementation by the target populations. The CE policy and manual should establish a common base of understanding and promote positive attitudes towards event reporting; and (3) ApplicabilityTarget populations are able to correctly identify which Critical Events have occurred at their sites and are able to apply the CE policy and manual to their events. Findings will provide data to inform DAIDS and Protection of Participants, Evaluation and Policy (ProPEP) leadership regarding further policy deployment decisions. Information collected will be used to determine how effectively the CEPI Program meets extramural researchers' needs. By assessing the CEPI Program, DAIDS will determine how successfully it is reaching its goalsto facilitate and improve the quality of clinical research conducted within the division. In addition, the CEPI Program assessment will determine whether previously recommended improvements included in the DPIP assessment were successfully incorporated into the policy rollout process. The results may be used as a model for policy development to facilitate compliance in reporting certain incidents and implementation in other National Institutes of Health (NIH) Institutes and Centers (ICs) and will be shared with all interested divisions and institutes within the NIH. There are no plans to share this information with the public. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 386.

HHS gives notice of a decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 27, 2014, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Proper Labeling of Honey and Honey Products.'' FDA developed this draft guidance to advise firms on the proper labeling of honey and honey products to help ensure that honey and honey products are not adulterated or misbranded.

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 a draft guidance for industry, researchers, patient groups, and FDA staff entitled ``Meetings With the Office of Orphan Products Development.'' This draft guidance provides recommendations to industry, researchers, patient groups, and other stakeholders (collectively referred to as ``stakeholders'') interested in requesting a meeting with FDA's Office of Orphan Products Development (OOPD) on issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. This draft guidance document is intended to assist these groups with requesting, preparing, scheduling, conducting, and documenting meetings with OOPD.

The Food and Drug Administration (FDA) is extending to May 7, 2014, the comment period for the notice that appeared in the Federal Register of January 7, 2014 (79 FR 830). In the notice, FDA requested comments on a draft guidance document entitled ``Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs.'' This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and the potential impact on immunogenicity.

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. 209 and 37 CFR part 404 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.