Department of Health and Human Services September 20, 2012 – Federal Register Recent Federal Regulation Documents

HHS gives notice of a decision to designate a class of employees from Winchester Engineering and Analytical Center in Winchester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to two current grantees, for a total of $2,659,864. The additional funding provided by the awards will support services to unaccompanied alien children through September 30, 2012. The supplement grant will support the expansion of bed capacity to meet the number of unaccompanied alien children referrals from the Department of Homeland Security (DHS). The funding program is mandated by Section 462 of the Homeland Security Act to ensure appropriate placement of all referrals from the DHS. The program is tied to DHS apprehension strategies and sporadic number of border crossers. One expansion supplement award is made to Florence Crittenton Services of Orange County, Inc., in Fullerton, CA, in the amount of $226,800 to support expansion of bed capacity to meet the needs of the high number of unaccompanied alien children transferred from the DHS. Award funds will support services to unaccompanied alien children through September 30, 2012. Two expansion supplement awards are made to International Education Services, Inc., in Los Fresnos, TX. One award for $1,588,827 will provide unaccompanied alien children with temporary 24-hour licensed shelter care in facilities in South Texas. The other award for $844,237 will support the International Education Services, Inc. Harlingen Foster Care Program that provides unaccompanied children with temporary 24-hour family care in private homes within the Cameron County in South Texas.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of 24 single-source program expansion supplement grants for a total of $60,835,955. The additional funding provided to current grantees under ORR's UAC program will support services to unaccompanied alien children through September 30, 2012. The ORR UAC grantees that have received single-source program expansion supplements are:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI) (OMB No. 0925-0613). Type of Information Collection Request: Revision. Need and Use of Information Collection: The U.S. Food and Drug Administration (FDA) holds the National Cancer Institute (NCI) responsible, as a sponsor of investigational drug trials, for the collection of information about the clinical investigators who participate in these trials and to assure the FDA that systems for accountability are being maintained by investigators in its clinical trials program. The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug. Investigators are physicians who specialize in the treatment of patients with cancer. Data obtained from the Drug Accountability Record is used to track the dispensing of investigational anticancer agents from receipt from the NCI to dispensing or administration to patients. NCI and/or its auditors use this information for compliance purposes. Frequency of Response: Up to 16 times per year. Affected Public: Private sector including businesses, other for-profit organizations, and non-profit institutions. Type of Respondents: Investigators, pharmacists, nurses, pharmacy technicians, and data managers. The annualized respondents' burden for record keeping is estimated to require 14,223 hours (see Table 1). There are no capital costs, operating costs, or maintenance costs.

HHS gives notice of a decision to designate a class of employees from Clarksville Modification Center, Ft. Campbell, in Clarksville, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, 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 availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for pentosan polysulfate sodium capsule.

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: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 27th, 2012 and allowed 60 days for public comment. Several comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on June 13th, 2012 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-ninth meeting. The meeting will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.hhs.gov/ohrp/sachrp/mtgings/ index.html.