Department of Health and Human Services August 2018 – Federal Register Recent Federal Regulation Documents

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease Study).'' The purpose of this research is to use sound study methods to see if drinking water exposure to PFAS is related to health outcomes in this New Hampshire community.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

HRSA is requesting nominations to fill vacancies on the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD is authorized by Section 749 of the Public Health Service (PHS) Act. The Advisory Committee is governed by provisions of the Federal Advisory Committee Act (FACA), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 749.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES).

The Food and Drug Administration (FDA or Agency), in response to suggestions submitted to Docket No. FDA-2008-N-0567, has analyzed whether Pneumocystis pneumonia (PCP) meets the statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), namely whether it primarily affects poor and marginalized populations and whether there is ``no significant market'' for drugs that prevent or treat PCP in developed countries. The Agency has determined that PCP does not meet the statutory criteria for designation as a tropical disease and declines to designate it as such.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 the Prescription Drug User Fee Cover Sheet, Form FDA 3397, that must be submitted along with certain drug and biological product applications.

This request for information (RFI) seeks input from the public regarding the Electronic Health Record (EHR) Reporting Program established as Section 4002 of the 21st Century Cures Act (Cures Act) codified Section 3009A in Title XXX of the Public Health Service Act (PHSA). This RFI is a first step toward implementing the statute. Its responses will be used to inform subsequent discussions among stakeholders and future work toward the development of reporting criteria under the EHR Reporting Program.

In accordance with the requirements of the Privacy Act of 1974, as amended (the Act), the Department of Health and Human Services (HHS) is providing notice of the establishment of a new system of records, System No. 09-90-1701, HHS Insider Threat Program Records. The new system of records will cover records about individuals, retrieved by personal identifier, which are compiled and used by the Department's Office of Security and Strategic Information (OSSI), within the Immediate Office of the Secretary (IOS), to administer the Department's insider threat program. Because the records in this system of records include investigatory material compiled for law enforcement purposes and information classified in the interest of national security, elsewhere in today's Federal Register HHS has published a Notice of Proposed Rulemaking (NPRM) to exempt this system of records from certain requirements of the Privacy Act, pursuant to subsections (k)(1) and (k)(2) of the Act. The system of records is more fully described in the SUPPLEMENTARY INFORMATION section of this notice and in the System of Records Notice (SORN) published in this notice.

ACF, ORR announces the solicitation and intent to issue one OPDIV-Initiated Supplement to Lutheran Immigration and Refugee Service, Inc., Baltimore, MD in an amount not to exceed $1,000,000. ORR has been identifying additional capacity for fingerprinting services for an expected increase in the number of sponsors (parents, guardians, or family friends to whom the UAC will be released) who will need to be fingerprinted. Planning for increased fingerprinting capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to ensure that the sponsor has not engaged in any activity that would indicate a potential risk to the UAC.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.'' The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). This draft guidance does not address improvement of symptoms of OA, such as pain or functional impairment, which will be addressed in future guidances.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 400. Time will be available for public comment.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``HIV prevention among Latina transgender women: Evaluation of a locally developed intervention''. The collection is part of a research study designed to evaluate the efficacy of a locally developed and culturally congruent two-session Spanish-language small-group intervention, ChiCAS (Chicas Creando Acceso a la Salud [Chicas: Girls Creating Access to Health]), which provides combination HIV prevention services to adult Hispanic/Latina transgender women at high risk for HIV infection.

NIOSH announces the availability of the final National Occupational Research Agenda for Wholesale and Retail Trade.

In accordance with the Privacy Act of 1974, as amended (the Act), the Department of Health and Human Services (HHS or Department) is proposing to exempt a new system of records, System No. 09-90-1701, HHS Insider Threat Program Records, from certain requirements of the Act.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Department of Health and Human Services, Administration for Children and Families (ACF) will host a Tribal Consultation to consult on ACF programs and tribal priorities.

The Food and Drug Administration (FDA or Agency) has determined that DANOCRINE (danazol) Capsules, 50 milligrams (mg), 100 mg, and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to suspend approval of abbreviated new drug applications (ANDAs) that refer to this drug product and have removed the indication for fibrocystic breast disease. This determination also will allow FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements. However, the Agency will not accept or approve ANDAs for DANOCRINE (danazol) Capsules, 50 mg, 100 mg, and 200 mg that include fibrocystic breast disease as an indication.