Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the draft Current Intelligence Bulletin (CIB) entitled ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/115/. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: December 14, 2007 through February 15, 2008. Public Meeting Time and Date: 9 a.m.-4 p.m., January 30, 2008. Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose of Meeting: To discuss and obtain comments on the draft CIB ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' Special emphasis will be placed on discussion of the following: (1) Do the data support the conclusions of the document? (2) Are the conclusions appropriate in light of the current understanding of toxicological data? (3) Is medical surveillance appropriate at this time for workers with potential exposure to engineered nanoparticles; if so, what form(s) of medical surveillance are specific for such workers? (4) What are the potential benefits, adverse impacts, and limitations of medical screening of workers potentially exposed to engineered nanoparticles? (5) What are the potential benefits, adverse impacts, and limitations of establishing an exposure registry for workers exposed to engineered nanoparticles? Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. The meeting room accommodates 80 people. Due to limited space and security clearance requirements, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than Friday, January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify the NIOSH Docket Office no later than January 11, 2008 at 513/533-8611 or by e-mail at nioshdocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first- come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-115 and must be submitted by February 15, 2008 (public review closing date) to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-115. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Background: Concerns have been raised about whether workers exposed to engineered nanoparticles will be at increased risk of adverse health effects and whether medical screening or some other type of occupational health surveillance is appropriate for these workers. Although increasing evidence indicates that exposure to some engineered nanoparticles can cause adverse health effects in laboratory animals, insufficient medical evidence exists to recommend the medical screening of workers potentially exposed to engineered nanoparticles. However, NIOSH will continue to assess the scientific evidence and periodically update the guidance on medical screening. Because occupational exposure to engineered nanoparticles is likely to become more common in the future, NIOSH has recommended that employers identify the presence of engineered nanoparticles in their workplace and implement effective efforts to minimize worker exposure to these materials [NIOSH 2006]. This guidance document does not have the force and effect of the law. Contact Persons for Technical Information: Dr. Paul A. Schulte, M/S C-14, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8302, or Ralph Zumwalde, M/S C-32, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8320. Reference: NIOSH [2006]. Approaches to safe nanotechnology: an information exchange with NIOSH. Cincinnati, OH: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, July 2006. Web address for this document: https://www.cdc.gov/niosh/topics/nanotech/safenano/.

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the certification to accompany human drug, biological product, and device applications or submissions.

The Food and Drug Administration (FDA) is issuing this notice, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), to establish the fiscal year (FY) 2008 fees that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. The Federal Food, Drug, and Cosmetic Act (the act), as amended by FDAAA, authorizes FDA to collect user fees for certain direct-to-consumer (DTC) television advertisements submitted to FDA for advisory review.

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 reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005 (70 FR 60751), (herein after referred to as the 2005 proposed rule). In that document, FDA proposed to amend its regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. FDA received a number of comments that were opposed to the proposed requirement to declare fluid UF milk, when used, as ``ultrafiltered milk'' or ``ultrafiltered nonfat milk,'' as appropriate, in the ingredient statement of the finished cheese. FDA is reopening the comment period on the 2005 proposed rule to seek further comment only on two specific issues raised by the comments concerning the proposed ingredient declaration.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Mental Models Study of Communicating With Health Care Providers About the Risks and Benefits of Prescription Drug Use for Pregnant and Nursing Women With Chronic Conditions. Together with other information being collected, the results from this study will be used to help inform FDA about how health care providers use prescription drug labeling and other available information in making treatment decisions and how that use differs from how agency experts believe such information is used. It will also contribute to FDA's ability to plan internal and external communications activities that address any misperceptions and gaps in understanding about prescription drug labeling.

In accordance with the Privacy Act of 1974, as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program (state TANF agencies).

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Intern and Resident Information System (IRIS), System No. 09-70-0524, last published at 67 Federal Register 48189 (July 23, 2002). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers increasingly more to specific beneficiary or recipient practices that result in unnecessary cost to Federally-funded health benefit programs. We will delete the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' does not apply because this system does not collect or maintain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' is not applicable to the data maintained in this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or by Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to ensure that no interns and residents (IRs) are counted by the Medicare program as more than one full-time equivalent (FTE) employee in the calculation of payments for the costs of direct graduate medical education (GME) and indirect medical education (IME). Information retrieved from this SOR will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant, (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent, (3) support providers and suppliers of services, (4) assist third-party contacts where necessary to establish or verify information, (5) support litigation involving the Agency, and (6) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Cross Vetpharm Group Ltd. The supplemental NADA provides for use of a 100 milligram per milliliter (mg/mL) strength erythromycin injectable solution in cattle for the treatment of bovine respiratory disease.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Massachusetts Institute of Technology, Cambridge, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Massachusetts Institute of Technology. Location: Cambridge, Massachusetts. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: August 13, 1942 through December 31, 1945; and Job Titles and/or Job Duties: All employees of the Department of Energy (DOE), its predecessor agencies, and DOE contractors or subcontractors, who worked in the Hood Building. Period of Employment: January 13, 1946 through December 31, 1963.

This notice cancels the standing program announcement for the Assets for Independence (AFI) Program (HHS-2005-ACF-OCS-EI-0053) that was published in the Federal Register on February 2, 2005. A new standing program announcement for the AFI program will be published at the Administration for Children and Families' Grant Opportunities Web page at https://www.acf.hhs.gov/grants/. The new standing program announcement and application package will also be available at www.grants.gov. Interested parties should register with www.grants.gov to receive e-mail alerts announcing publication, application due dates, and application requirements.

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S. Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement section 572 of the act entitled ``Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' These regulations establish administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Voluntary Questionnaire and Data Collection Testing to Pretest Home Health Care CAHPS Questions and Methodology.'' This activity is being conducted under AHRQ's generic pre-testing clearance OMB 0935-0125. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. Sec. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs.

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. 207 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.