Department of Health and Human Services February 2011 – 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 good laboratory practice (GLP) for nonclinical laboratory studies regulations.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

The NTP announces the availability of draft NTP Technical Reports (TRs; available at https://ntp.niehs.nih.gov/go/36051) that will be peer-reviewed by an NTP Technical Reports Peer Review Panel at a meeting on April 5, 2011. The meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). Summary minutes from the peer review will be posted on the NTP Web site following the meeting.

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: cancer Biomedical Informatics Grid [supreg] (caBIG [supreg]) Support Service Provider (SSP) Program (NCI). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The NCI Center for Biomedical Informatics and Information Technology (CBIIT) launched the enterprise phase of the caBIG [supreg] initiative in early 2007 with an emphasis on widespread institutional adoption of the program and tools. This emphasis on adoption has generated an expanding community with diverse needs for support, which are met through the resources available through the caBIG [supreg] Enterprise Support Network (ESN), including the caBIG [supreg] Support Service Provider (SSP) Program. The caBIG [supreg] SSPs provide caBIG [supreg] end-users with the freedom to match what caBIG [supreg] has to offer to their unique organizational goals and needs, so having this customized support option available is critically important to advancing the goals of the caBIG [supreg] program. caBIG [supreg] SSP applicants are evaluated against well-defined criteria published in the SSP Program Announcement and must successfully demonstrate that they have the technical capabilities, staffing and scalability, geographic coverage (when applicable), and the domain expertise in biomedicine to effectively serve caBIG [supreg] users. The information submitted by SSP applicants enables NCI to determine whether such applicants are qualified to enter into trademark license negotiations with NCI to use the caBIG [supreg] trademarks in connection with their services and become designated as caBIG [supreg] SSPs. Thus, the collection of information from SSP applicants is critical to both ensuring that the goals and objectives of the caBIG [supreg] program will be maintained and furthered by the organizations designated as SSPs and facilitating NCI's ability to exercise appropriate stewardship of the caBIG [supreg] trademarks. Sections 410 and 411 of the Public Health Service Act (42 U.S.C. 285 and 285a) authorize the collection of the information. Frequency of Response: once for the applicants. caBIG [supreg] SSP applications are accepted on a rolling basis and reviewed several times a year. Affected Public: Private sector including Business or other for-profits and not-for-profit organizations and institutions. Type of Respondents: Technical representatives of commercial, academic or not- for-profit organizations. The annual reporting burden is estimated at 360 hours. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is issuing a proposed rulemaking to amend the tentative final monograph (1985 TFM) for over- the-counter (OTC) laxative drug products (products that relieve occasional constipation). FDA is proposing that sodium phosphate salts (dibasic sodium phosphate, monobasic sodium phosphate, and the combination of dibasic sodium phosphate/monobasic sodium phosphate salts in a solution dosage form) are not generally recognized as safe (GRAS) for bowel cleansing. This document also would withdraw the professional labeling proposed for sodium phosphate salts in the 1985 TFM. Professional labeling is additional information about an OTC drug that is directed to healthcare professionals who prescribe, administer, or dispense medications and is not included in OTC drug product labeling for consumers. FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution (approximately 60 grams (g) of sodium phosphates taken in two 45-milliliter (mL) doses 12 hours apart or approximately 50 g of sodium phosphates taken in a 45-mL dose followed by a 30-mL dose 12 hours later) for bowel cleansing prior to colonoscopy. This proposed rule is part of FDA's ongoing review of OTC drug products.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from BWX Technologies, Inc., Lynchburg, Virginia, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 6, 2011, 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:

Oregon Patient Safety Commission: AHRQ has accepted a notification of voluntary relinquishment from Oregon Patient Safety Commission of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

Quality Excellence Inc./PSO: AHRQ has accepted a notification of voluntary relinquishment from Quality Excellence Inc./PSO, a component entity of Arkansas Foundation for Medical Care, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a P50 an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

Community Medical Foundation for Patient Safety: AHRQ has accepted a notification of voluntary relinquishment from Community Medical Foundation for Patient Safety, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41,42 U.S.C. 299b-21 b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

The Presidential Commission for the Study of Bioethical Issues will conduct its fourth meeting. At this meeting, the Commission will discuss genetics, neuroscience, and neuroimaging for testing, research, diagnosis, risk identification, and health promotion. The Commission will also begin a review of human subjects protection.