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

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).

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 establishment of a public docket for comments pertaining to the report mandated under the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 1138, enacted July 9, 2012, and posted on the FDA Web site on July 9, 2013. This docket is intended to solicit input on this report from all relevant stakeholders.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to FDA regulations for human tissue intended for transplantation.

HRSA is publishing Agency Guidance (``Policy Information Notice'' (PIN) 2013-01) to provide clarification on the budgeting and accounting requirements for federally-funded health centers and Look- Alikes. The PIN, ``Health Center Budgeting and Accounting Requirements'' is available on the Internet at https://bphc.hrsa.gov/ policiesregulations/policies/pin201301.html. Background: HHS' Health Resources and Services Administration (HRSA) provides grants to eligible health centers under section 330 of the Public Health Service Act to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. In 2012, grants helped fund more than 1,200 health center grantees that provided services at nearly 9,000 health care delivery sites and served more than 21 million people. There are also over 100 Look-Alikes. Look-Alikes, as described in section 1861(aa)(4) and section 1905(l)(2)(B) of the Social Security Act, do not receive federal funding under section 330 of the PHS Act; however, to receive the Look-Alike designation and benefits, Look-Alikes must meet the statutory, regulatory, and policy requirements for health centers programs under section 330. Under 45 CFR Part 74, a key requirement of the Health Center Program is for a health center to establish a budget that reflects the cost of operations, expenses, and revenues necessary to accomplish the service delivery plan. All section 330-funded health centers and Look- Alikes must prepare a budget that meets these requirements. The purpose of this PIN is to provide clarification regarding budgeting and accounting requirements for health centers to ensure transparency and accountability. In addition to making the final PIN available on HRSA's Web site, HRSA is also making available a section of this PIN for public comment. HRSA will review and analyze all comments on this section and issue final PIN. When finalized, this section of the PIN will supersede all other previous Health Center Program guidance and policy issued on this program requirement.

HRSA will be issuing a grantee transfer without competition for the Detroit Michigan Healthy Start program to the Institute for Population Health (IPH). The IPH will assume responsibility for the Healthy Start program and receive year 5 funding in the amount of $1,575,000, from Grant Number H49MC00147, during the budget period of 6/1/2013-5/31/2014 to support the objectives of the Eliminating Disparities in Perinatal Health Healthy Start Program. The Eliminating Disparities in Perinatal Health Healthy Start Program (H49), CFDA No. 93.926, is authorized by the Public Health Service Act, Title III, Part D, Section 330H (42 USC 254c-8). The purpose of the Eliminating Disparities in Perinatal Health Healthy Start Program is to address significant disparities in perinatal health. Differences in perinatal health indicators may occur by virtue of education, income, disability, or living in rural/isolated areas. To address disparities and the factors contributing to them, project services have been designed to cover the pregnancy and interconceptional phases for women and infants residing in the proposed project area. In order to promote longer interconceptional periods and prevent relapses of risk behaviors, the women and infants are to be followed through the infant's second year of life and/or two years following delivery.

HRSA will be transferring the Michigan Family-to-Family Health Information Center (F2F HIC) grant (H84MC09365) from the Family Center for Children and Youth with Special Health Care Needs (FCCYSHCN) in Detroit, Michigan, to the Michigan Public Health Institute (MPHI) in Okemos, Michigan, to ensure the continued provision of health resources, financing, related services, and parent-to-parent support for families with children and youth with special health care needs (CYSHCN) in the state of Michigan.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with medical devices third-party review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended to update FDA's policy and to further clarify FDA's interpretations of the regulation requirements and, when final, will supersede the previous manufacturer guidances issued in 1988 and 1997. This draft guidance also provides answers to frequently asked questions and includes a section on common reporting errors. This draft guidance is not final nor is it in effect at this time.

This notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, indicates that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive commercialization license to practice the inventions embodied in: (a) Technology families E-047-1994/0 and E-047-1994/1, including U.S. Patent 5,635,599 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-US-01], PCT Application PCT/ US95/04468 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/0-PCT-02], European Patent 0754192 entitled ``Proteins Comprising Circularly Permuted Ligand'' [HHS Ref. E-047-1994/0-EP-15, validated in Austria, Belgium, France, Italy, Liechtenstein, The Netherlands, Spain, Switzerland and the United Kingdom], Canadian Patent 2187283 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], Australian Patent 694211 entitled ``Proteins Comprising Circularly Permuted Ligands'' [HHS Ref. E-047-1994/0-CA-14], and U.S. Patent 6,011,002 entitled ``Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules'' [HHS Ref. E-047-1994/1-US-01]; (b) Technology family E-021-2010/0, including U.S. Patent Application 61/105,408 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-01] and U.S. Patent Application 12/ 579,281 entitled ``Targeted Cargo Protein Combination Therapy'' [HHS Ref. E-021-2010/0-US-02]; and all related continuing and foreign patents/patent applications for these technology families, to Medicenna Therapeutics, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective start-up exclusive commercialization license territory may be worldwide, and the field of use may be limited to: