Department of Health and Human Services January 2014 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) Office of the Secretary announces establishment of the National Advisory Committee on Children and Disasters (NACCD). The Advisory Committee will provide advice and consultation to the HHS Secretary on pediatric medical disaster planning, preparedness, response, and recovery with respect to the medical and public health needs of children in relation to disasters. The Office of the Assistant Secretary for Preparedness and Response (ASPR) shall provide management and administrative oversight to support the activities of the Advisory Committee. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NACCD. Up to six new voting members with expertise in pediatric medical disaster planning, preparedness, response, or recovery will be selected for the Committee in the following categories: Non-federal health care professionals and representatives from state, local, territorial, or tribal agencies. Please visit the NACCD Web site at www.phe.gov/naccd for all application submission information and instructions. Application submissions will be accepted for 30 calendar days from the date this posting is published in the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of two new animal drug applications (NADAs) held by Argent Laboratories. Withdrawal of approval of these NADAs was at the sponsor's request because the products are no longer manufactured or marketed.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License Agreement to Paris Therapeutics, a company having a place of business in Santee, CA, to practice the inventions embodied in the following patent applications:

The Department of Health and Human Services (HHS) proposes to amend its regulations pertaining to occupational safety and health investigations of places of employment conducted by the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC), to update outdated terminology and strike references to obsolete government offices or divisions. These proposed changes will not affect current practices.

Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2013 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal Organizations that receive FY 2014 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), Title XXVI of the Omnibus Budget Reconciliation Act of 1981 (42 U.S.C. 8621 et seq.), as amended, requires that if the Secretary of the U.S. Department of Health and Human Services (HHS) determines that, as of September 1 of any fiscal year, an amount in excess of certain levels allotted to a grantee for any fiscal year will not be used by the grantee during the fiscal year, the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be realloted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. (No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2014.) It has been determined that $2,192,230 may be available for reallotment during FY 2014. This determination is based on revised Carryover and Reallotment Reports from the State of Nebraska, Salt River Pima-Maricopa Indian Community, and the Delaware Tribe of Indians, which were submitted to the Office of Community Services as required by 45 CFR 96.82. The statute allows grantees who have funds unobligated at the end of the federal fiscal year for which they are awarded to request that they be allowed to carry over up to 10 percent of their allotments to the next federal fiscal year. Funds in excess of this amount must be returned to HHS and are subject to reallotment under section 2607(b)(1) of the Act. The amount described in this notice was reported as unobligated FY 2013 funds in excess of the amount that the State of Nebraska, Salt River Pima-Maricopa Indian Community, and the Delaware Tribe of Indians could carry over to FY 2014. Each of the grantees mentioned above were notified and confirmed that the FY 2013 funds indicated in the chart below may be reallotted. In accordance with section 2607(b)(3), the Chief Executive Officers of the grantees referenced in the chart below have 30 days from the date of this publication to submit comments to: Jeannie L. Chaffin, Director, Office of Community Services, 370 L'Enfant Promenade, SW., Washington, DC 20447. After considering any comments submitted, the Chief Executive Officers will be notified of the final reallotment amount, and this decision also will be published in the Federal Register. If funds are reallotted, they will be allocated in accordance with section 2604 of the Act and must be treated by LIHEAP grantees receiving them as an amount appropriated for FY 2014. As FY 2014 funds, they will be subject to all requirements of the Act, including section 2607(b)(2), which requires that a grantee obligate at least 90 percent of its total block grant allocation for a fiscal year by the end of the fiscal year for which the funds are appropriated, that is, by September 30, 2014.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.'' This guidance is intended to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages. This guidance also is intended to remind dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements; namely, those that are not dietary ingredients as defined in the FD&C Act.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 033'' (``Recognition List Number: 033''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format.'' The draft guidance is intended to alert stakeholders to changes we are planning for the administrative procedures currently used by commercial processors that manufacture, process, or pack acidified foods (AF) and/ or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as ``low-acid canned foods'' or ``LACF''). These changes include new food process filing forms and a new ``smart form'' system for electronic submission of these forms. The draft guidance, when finalized, will supersede the July 2012 guidance entitled ``Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541a and FDA 2541c (Food Process Filing Forms) to FDA in Electronic or Paper Format'' when the new food process filing forms and the new ``smart form'' electronic system become operational.

The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the pharmacy compounding industry and the pharmaceutical manufacturing industry on the Pharmacy Compounding Advisory Committee for the Center for Drug Evaluation and Research notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for two vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the pharmacy compounding industry and the pharmaceutical manufacturing industry.

The Food and Drug Administration (FDA) is requesting nominations for 12 voting members to serve on the Pharmacy Compounding Advisory Committee, Center for Drug Evaluation and Research. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups.