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

Peer review meeting of the Draft Report on Carcinogens (RoC) Monographs for 1-Bromopropane and Cumene. These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application, i.e., a biologics license application (BLA), a new drug application (NDA), or a device premarket approval application (PMA).

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act), and the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). This proposed rule reflects new statutory eligibility provisions; proposes changes to provide states more flexibility to coordinate Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices, appeals, and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act; modernizes and streamlines existing rules, eliminates obsolete rules, and updates provisions to reflect Medicaid eligibility pathways; revises the rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; implements other CHIPRA eligibility-related provisions, including eligibility for newborns whose mothers were eligible for and receiving Medicaid or CHIP coverage at the time of birth; amends certain provisions included in the ``State Flexibility for Medicaid Benefit Packages'' final rule published on April 30, 2010; and implements specific provisions including eligibility appeals, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also proposes to update and simplify the complex Medicaid premiums and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities.

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 invites comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Health (OASH), 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, OASH seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) seeks comment on the types of hazard identification and risk management research that should be considered for updating the NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016) can be found in Docket CDC-2013-0001 at https://www.regulations.gov.

This document corrects a notice that was published in the Federal Register on January 7, 2013 (78 FR 949-950). The 10th Biannual Tribal Consultation session has been postponed to coincide with the summer 2013 meetings; the dates will be announced once they are determined. The Tribal Advisory Committee Meeting will be extended and held February 5, 6, and 7, 2013, from 8:00 a.m.-4:30 p.m.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory (LANL), in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as further amended by the FDA User Fee Corrections Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. This document establishes the FY 2013 rate for API and FDF facility fees. These fees are due on March 4, 2013.