Department of Health and Human Services June 2012 – Federal Register Recent Federal Regulation Documents

On February 10, 2012, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) published a Direct Final Rule (DFR) that solicited public comment on the establishment of user fees for filovirus testing of all nonhuman primates that die during the HHS/CDC-required 31-day quarantine period for any reason other than trauma. That document incorrectly listed the effective date as March 12, 2012. On February 10, 2012, HHS/CDC also published in the Federal Register a companion Notice of Proposed Rulemaking (NPRM) (77 FR 7109) that proposed identical filovirus testing and user fee requirements. In both the DFR and NPRM, HHS/CDC indicated that if it did not receive any significant adverse comments by April 10, 2012, it would publish a document in the Federal Register withdrawing the NPRM and confirming the effective date of the DFR within 30 days after the end of the comment period. Because of the error in effective date the DFR took effect prior to the expiration of the comment period. Because of this error and due to receiving significant adverse public comments, HHS/CDC is amending 42 CFR 71.53 by removing paragraph (j) which will have the same effect as the withdrawal of the DFR. HHS/CDC will carefully review the comments received on the notice of proposed rulemaking published on February 10, 2012.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions (OMB No. 0917-0028). Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0028, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions.'' Although there was a change on the form ``Addendum to Declaration for Federal Employment, Child care and Indian Child care Worker Positions'' (OMB No. 0917-0028), where the item number 15a was changed to 16 to reflect a change in the same item number on the ``Declaration for Federal Employment'' form (OPM OF 306; OMB No. 3206-0182), there are no program changes or adjustments in burden hours. Form Number: OMB No. 0917-0028. Forms: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions. Need and Use of Information Collection: This is a request for approval of the collection of information as required by Section 408 of the Indian Child Protection and Family Violence Prevention Act, Public Law (Pub. L.) 101-630, 104 Stat. 4544, and 25 United States Code (U.S.C.) Sec. Sec. 3201-3211. The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. 25 U.S.C. Sec. 3207 requires regulations prescribing the minimum standards of character to ensure that none of the individuals appointed to positions involving regular contact with, or control over, Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution; crimes against persons; or offenses committed against children. In addition, 42 U.S.C. Sec. 13041 requires each agency of the Federal Government, and every facility operated by the Federal Government (or operated under contract with the Federal Government), that hires (or contracts for hire) individuals involved with the provision of child care services to children under the age of 18 to assure that all existing and newly hired employees undergo a criminal history background check. The background investigation is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal Government, or for a facility or program operated by (or through contract with) the Federal Government, in positions involved with the provision of child care services to children under the age of 18, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).

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 information collection provisions of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) and the guidance document entitled ``Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.''

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 31, 2012 (77 FR 32124). The document announced the availability of a guidance for industry entitled ``Irritable Bowel SyndromeClinical Evaluation of Drugs for Treatment.'' The document was published with an incorrect docket number. This document corrects that error.

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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation,'' dated January 19, 2001.

The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES).

The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 Office of Strategic Coordination (OSC), Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), 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: Process Evaluation of the Early Independence Award (EIA) Program. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the EIA program operations. The primary objectives of the study are to (1) assess if the requests for applications (RFAs) are meeting the needs of applicants, (2) document the selection process, (3) document EIA program operations, (4) assess the progress being made by the Early Independence Principal Investigators, and (5) assess the support provided by the Host Institutions to the Early Independence Principal Investigators. The findings will provide valuable information concerning (1) aspects of the program that could be revised or improved, (2) progress made by the Early Independence Principal Investigators, and (3) implementation of the program at Host Institutions. Frequency of Response: On occasion. Affected Public: None. Type of Respondents: Applicants, reviewers, and awardees. The annual reporting burden is as follows: Estimated Number of Respondents: 390; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 4; and Estimated Total Annual Burden Hours Requested: 158. The annualized cost to respondents is estimated at: $9,774. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 77 on February 23, 2012, page 10756, and allowed 60-days for public comment. Six written comments were received, one of which was shared by two signatories. One comment was a personal opinion regarding the current federal blood donation policy for men who have sex with men. Two of the written comments supported the study goals and design as proposed. Three of the written comments suggested changes to some of the questions, or asked whether the scope of the study could be expanded. As a result, content pertaining to the sexual histories of survey respondents was expanded to inform the broader context for the current policy for men who have sex with men. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Opinions and Perspectives about the Current Blood Donation Policy for Men Who Have Sex with Men. Type of Information Collection Request: New. Need and Use of Information Collection: The current policy for blood donation in the U.S. with respect to men who have sex with men (MSM) is that any man who discloses having had sex with another man since 1977 is deferred indefinitely from donating. However, data from donors who have tested disease marker positive and were interviewed regarding potential risk factors suggest that some individuals continue to donate blood without disclosing MSM activity in contravention of the policy. In the 1980s there were surveillance studies of risk factors among donors who were determined to be HIV positive in pre-donation testing: Results indicated MSM behavior to be a risk factor for 56% of male donors. In addition, as part of the Retrovirus Epidemiology Donor Study (REDS), when anonymously surveyed by paper and pencil mailed surveys, 1.2% of male blood donors reported MSM behavior. In a 2007 study conducted in Sweden, 19% of 334 MSM who responded to a survey that was included in a monthly publication targeted to the Lesbian, Gay, Bisexual and Transgender (LGBT) community reported donating blood at least one-time since 1985. The authors suggested that MSM donors may be motivated by perceived discrimination, particularly younger MSM. Recent publications from the United Kingdom have reported what are likely the only population-based assessment of non-compliance with a similar restriction on blood donation for the MSM population as in the U.S.; this study was conducted in 2009 and 2010 and also estimated opinions about and self-reported intended compliance with the MSM deferral policy in place in the United Kingdom at that time. Note, the policy in the United Kingdom was modified in November 2011 and MSM in the United Kingdom are now allowed to donate if they have not been sexually active for a one-year period before donation. Data similar to those collected in Sweden and the United Kingdom are not available for the U.S. Potential changes to the current MSM policy for blood donation requires additional data, including information about motivating factors and compliance with the current MSM policy or a modified policy in the MSM population and in current blood donors. Speculative analyses have been conducted but do not directly address important considerations related to this policy such as the current level of compliance (in the MSM population) and non- compliance (in the blood donor population). While many scientists and ethicists have expressed opinions in support or against modification of the current MSM policy for blood donation, there is a lack of data that directly addresses important aspects of this policy debate. The proposed study will build off the studies conducted in Sweden and the United Kingdom and will collect directly relevant information on this topic by estimating the prevalence of compliance and non-compliance with the current MSM policy and assessing motivations for blood donation in the U.S. MSM population. Three research aims drive this study's protocols to provide valuable evidence on the motivations and compliance behaviors in the MSM and blood donor populations. The four geographic areas where the study will be conducted include the State of Connecticut, Western Pennsylvania, Southern Wisconsin, and the Bay Area of California. The first aim seeks to assess opinions about and common themes within the MSM population with respect to blood donation and the current MSM policy. Specifically, within a population of self- identified MSM in the U.S., what common themes can be identified regarding knowledge and opinions of current blood donation eligibility, and would opinions, including self-reported intended compliance, improve if the current MSM policy were changed to a deferral of a defined shorter duration? Another objective is to use what is learned in the focus groups to help select proper venues for identifying MSM who might be interested in participating in a comprehensive survey to assess compliance and non-compliance with the current MSM policy (see second aim). The second aim seeks to assess compliance and non-compliance in the MSM population with the current MSM blood donation policy by confidentially surveying two populations. One survey will be conducted in the MSM community to provide better estimates of compliance and non- compliance with the current policy and a second survey will be conducted in male blood donors to evaluate how frequently men who have had sex with another man since 1977 are donating blood. The surveys will be conducted using an instrument that includes common content to maximize the comparability of the responses. Both surveys will be conducted using Internet-based techniques and currently available software (SurveyGizmo, www.surveygizmo.com). The third aim seeks to assess motivations for donating in the group of self-identified MSM who are active blood donors in the U.S. Participants from the four geographic areas who report donating blood or the intention to donate will be asked to participate in confidential qualitative telephone interviews to identify their reasons for donating or wanting to donate blood. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Males 18 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 4864; Estimated Number of Responses per Respondent: 1 per respondent for 4844 respondents and 2 per respondent for 20 respondents; Average Burden of Hours per Response: 1.5 hours for Aim 1, 0.33 hour for Aim 2, and 1.0 hour for Aim 3; and Estimated Total Annual Burden Hours Requested: 1,700. The annualized total cost to all respondents is estimated at: $13,600 (based on $8.00 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 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: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection Request: NEW. Need and Use of Information Collection: New England Research Institutes as a contractor for the National Heart Lung and Blood Institute is planning to create an engaging, informational ``serious video game'' for adolescents about clinical studies which: (1) Incorporates core learning objectives; and (2) dispels misconceptions. Two types of information collection are planned: usability testing to understand game-play/usability. This information will be collected by focus group and will be digitally recorded 90 minute groups. A pre/post randomized trial to measure change in knowledge. This information will be collected electronically through on-line questionnaire. The game will be incorporated with a larger initiative to provide information about clinical research (https://www.nhlbi.nih.gov/ childrenandclinicalstudies/index.php). Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adolescentsaged 8- 14. The annual reporting burden is as follows: Estimated Number of Respondents: 6,148; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 1.321; and Estimated Total Annual Burden Hours Requested: 370. The annualized cost to respondents is estimated at: $3,700. There are no Capital Costs to report. The Operating Costs to collect this information is estimated at $38,642.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has developed a draft NICEATM-ICCVAM Five-Year Plan. The plan describes four core strategies to foster and promote development, validation, and regulatory acceptance of scientifically sound alternative test methods by the Federal government and by other governments and multinational organizations. This document will provide strategic direction for NICEATM and ICCVAM during 2013-2017. NIEHS and NICEATM request public comments on the draft 2013-2017 Five-Year Plan, which is available at https://iccvam.niehs.nih.gov/docs/ 5yearplan.htm. NICEATM and ICCVAM in partnership with relevant agency program offices will consider these comments during development of the final plan.

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: ``Adapting Best Practices for Medicaid Readmissions.'' 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 March 28th, 2012 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. The WTC Health Program, which is administered by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), provides medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors of the New York City attacks. In accordance with our regulations, which establish procedures for adding a new condition to the list of health conditions covered by the WTC Health Program, this proposed rule would add certain types of cancer to the List of WTC-Related Health Conditions.

The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled ``Draft Guidance on Considerations in Transferring a Previously-Approved Research Project to a New IRB or Research Institution,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/newsroom/rfc/ index.html, is intended primarily for institutional review boards (IRB), institutions, and investigators that are responsible for the review, conduct, or oversight of human subjects research conducted or supported by HHS. OHRP will consider comments received before issuing the final guidance document.

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.

NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Clarksville Facility in Clarksville, Tennessee, 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: Clarksville Facility. Location: Clarksville, Tennessee. Job Titles and/or Job Duties: Workers potentially exposed to radioactive materials while working at the Clarksville facility. Period of Employment: January 1, 1949 to December 31, 1967.