Department of Health and Human Services June 14, 2012 – Federal Register Recent Federal Regulation Documents

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.