Department of Health and Human Services February 2013 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 347
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-04443
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
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.
Prospective Grant of Exclusive License: Food Quality Indicators
Document Number: 2013-04442
Type: Notice
Date: 2013-02-27
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive patent license to practice the inventions embodied in: HHS Ref. No. E-093-1997/0 ``Food Quality Indicator;''
Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review
Document Number: 2013-04335
Type: Rule
Date: 2013-02-27
Agency: Department of Health and Human Services
This final rule implements provisions related to fair health insurance premiums, guaranteed availability, guaranteed renewability, single risk pools, and catastrophic plans, consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The final rule clarifies the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This final rule also amends the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under the federal rate review program, and revises the timeline for states to propose state- specific thresholds for review and approval by the Centers for Medicare & Medicaid Services (CMS).
Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
Document Number: 2013-04422
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 reinstatement 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 contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).
Submission for OMB Review; Comment Request
Document Number: 2013-04421
Type: Notice
Date: 2013-02-26
Agency: Department of Health and Human Services, Administration for Children and Families
Richard Stowell: Debarment Order
Document Number: 2013-04389
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Richard Stowell for a period of 3 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Stowell was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 14, 2012, Mr. Stowell had not responded. Mr. Stowell's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products
Document Number: 2013-04387
Type: Rule
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.
Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability
Document Number: 2013-04386
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2011 and replaces the guidance entitled, ``Guidance for Industry: Financial Disclosure by Clinical Investigators,'' dated March 2001.
Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Availability
Document Number: 2013-04384
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma'' dated February 2013. The guidance document recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.2 dated September 2012, as an acceptable mechanism that is consistent with FDA's requirements and recommendations for collecting Source Plasma donor history information. The Plasma Protein Therapeutics Association (PPTA) Source Plasma donor history questionnaires and accompanying materials (SPDHQ documents) will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2011.
Request for Public Comment on the Proposed Adoption of Administration for Native Americans Program Policies and Procedures
Document Number: 2013-04383
Type: Notice
Date: 2013-02-26
Agency: Department of Health and Human Services, Administration for Children and Families
Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2013 Funding Opportunity Announcements (FOA) for the following programs: (1) Social and Economic Development Strategies (hereinafter referred to as SEDS); (2) Native Asset Building Initiative (hereinafter referred to as NABI); (3) Sustainable Employment and Economic Development Strategies (hereinafter referred to as SEEDS); (4) Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation); (5) Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as LanguageEMI); and 6) Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice of public comment also provides additional information about ANA's plan for administering the programs.
Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013; Public Conference
Document Number: 2013-04331
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Seventh Annual DIA/FDA Statistics Forum2013.'' The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical investigators who are involved in the development of new drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's ``Critical Path'' initiativeemphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress being made in designing and implementing innovative solutions.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-04313
Type: Notice
Date: 2013-02-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 1, 2013
Document Number: 2013-04288
Type: Notice
Date: 2013-02-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, May 1, 2013. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on selected genetic tests for cancer diagnosis (for cancers of unknown primary site and for cervical cytology findings of uncertain clinical significance). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Submission for OMB Review; Comment Request
Document Number: 2013-04284
Type: Notice
Date: 2013-02-26
Agency: Department of Health and Human Services, Administration for Children and Families
Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis; Availability
Document Number: 2013-04281
Type: Notice
Date: 2013-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The draft guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice replaces the draft guidance entitled, ``Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis,'' dated June 2003. In addition, the draft guidance, when finalized, is intended to supersede the FDA memorandum to registered blood establishments dated December 12, 1991, entitled, ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''
Submission for OMB Review; Comment Request
Document Number: 2013-04278
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-04270
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2013-04256
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Office of Health Assessment and Translation Approach for Systematic Review and Evidence Integration for Literature-Based Health Assessments-February 2013; Request for Comments; Notice of a Meeting
Document Number: 2013-04254
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) requests public comments on the Draft Office of Health Assessment and Translation (OHAT) Approach for Systematic Review and Evidence Integration for Literature- Based Health AssessmentsFebruary 2013 (available at http:// ntp.niehs.nih.gov/go/38138). The NTP also plans to release two protocols to illustrate the application of this framework. These documents were prepared by the OHAT, Division of NTP, National Institute of Environmental Health Sciences (NIEHS). The NTP will hold a public web-based, informational meeting during the public-comment period to provide an overview of the framework, describe the contents in the case-study protocols, and respond to questions from the public on any of the documents.
Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance
Document Number: 2013-04251
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in the Federal Register on May 2, 2006. The guidance explained FDA's then current thinking on the labeling of certain uses of lecithin derived from soy under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and was part of FDA's implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA). We are taking this action because the policy stated in the guidance regarding FDA's consideration of the exercise of enforcement discretion no longer reflects our current thinking.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-04233
Type: Notice
Date: 2013-02-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Fecal Microbiota for Transplantation; Public Workshop
Document Number: 2013-04232
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-04215
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-04213
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2013-04212
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04211
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-04210
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-04209
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-04208
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development Notice of Closed Meeting
Document Number: 2013-04207
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-04206
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-04205
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-04204
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-04203
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
Document Number: 2013-04201
Type: Proposed Rule
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data; Availability
Document Number: 2013-04196
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of anti-HCV products.
Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements; Availability
Document Number: 2013-04195
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological ProductsImplementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear; useful; informative; and to the extent possible, consistent in content and format. It will assist applicants in developing labeling for new products, revising existing labeling, and implementing the requirements on content and format of labeling for human prescription drug and biological products (71 FR 3922), which appeared in the Federal Register of January 24, 2006. The rule is commonly referred to as the ``Physician Labeling Rule'' (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care practitioners.
Notice of Meeting
Document Number: 2013-04181
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2013-04176
Type: Notice
Date: 2013-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-04152
Type: Notice
Date: 2013-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee; Notice of Meeting.
Document Number: 2013-04141
Type: Notice
Date: 2013-02-25
Agency: Food and Drug Administration, Department of Health and Human Services
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2013-04139
Type: Proposed Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.
Control of Communicable Diseases: Interstate; Scope and Definitions
Document Number: 2013-04137
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75880).
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2013-04136
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is publishing this document to confirm the effective date of the Direct Final Rule (DFR), published on December 26, 2012 (77 FR 75939).
Control of Communicable Diseases: Foreign; Scope and Definitions
Document Number: 2013-04131
Type: Proposed Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is withdrawing a previously published Notice of Proposed Rulemaking (NPRM) that solicited public comment on updates to the Scope and Definitions for its regulations.
Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation
Document Number: 2013-04084
Type: Rule
Date: 2013-02-25
Agency: Department of Health and Human Services
This final rule sets forth standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this final rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This rule also finalizes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and amends regulations providing an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
Agency Information Collection Activities: OMB Review; Comment Request
Document Number: 2013-04135
Type: Notice
Date: 2013-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Collection; Comment Request: Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System Data Access Request
Document Number: 2013-04130
Type: Notice
Date: 2013-02-22
Agency: Department of Health and Human Services, National Institutes of Health
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 Institute of Neurological Disorders and Stroke (NINDS), 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. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Submission for OMB review; Comment Request: Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study
Document Number: 2013-04128
Type: Notice
Date: 2013-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 26, 2012, Vol. 77, No. 227, p. 70451 and allowed 60-days for public comment. Two comments were received in support of this request. 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: Cognitive Testing of Instrumentation and Materials for Population Assessment of Tobacco and Health (PATH) Study. Type of Information Collection Request: New. Need and Use of Information Collection: The PATH study will establish a population- based framework for monitoring and assessing the behavioral and health impacts of regulatory provisions implemented as part of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) by the Food and Drug Administration (FDA). NIDA is requesting generic approval from OMB for methodological studies to improve the PATH study instrumentation and data collection procedures. These methodological studies will support ongoing assessment and refinement of the PATH study's design, and highlight ways to improve study implementation, data collection procedures, and techniques for retention and followup. Data collection methods to be used in these methodological studies include: in-person and telephone surveys; web and smartphone/mobile phone surveys; and focus group and individual in-depth qualitative interviews. Biospecimens may also be collected from adults. Frequency of Response: Annual [As needed on an on-going and concurrent basis]. Affected Public: Individuals. Type of Respondents: Youth (ages 12-17) and Adults (ages 18+). Annual Reporting Burden: See Table 1. The annualized cost to respondents is estimated at: $371,284. There are no capital, operating or maintenance costs.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-04120
Type: Notice
Date: 2013-02-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services