Department of Health and Human Services October 25, 2013 – Federal Register Recent Federal Regulation Documents

Turtles Intrastate and Interstate Requirements
Document Number: C1-2013-17751
Type: Rule
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee; Urology Subcommittee Workshop
Document Number: 2013-25278
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
The Urology Subcommittee of the Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee (KUHICC) will hold a 1-day workshop on November 4, 2013. The workshop will be open to the public, with attendance limited to space available.
Notice of Vitamin D Standardization Program (VDSP) Symposium: Tools To Improve Laboratory Measurement
Document Number: 2013-25277
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health, Office of Dietary Supplements (ODS), and the National Institute of Standards and Technology (NIST), are sponsoring a one-day symposium on November 14, 2013, to present information about the Vitamin D Standardization Program (VDSP) to those with an interest in the effort to standardize vitamin D measurement. These groups include commercial assay manufacturers; commercial, clinical, and research laboratory personnel; vitamin D researchers; and members of professional societies with clinical and public health interest in vitamin D.
HIV/AIDS Bureau; Ryan White HIV/AIDS Program Core Medical Services Waiver; Application Requirements
Document Number: 2013-25276
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program or RWHAP), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the statute. The statute also grants the Secretary authority to waive this requirement if there are no waiting lists for the AIDS Drug Assistance Program (ADAP) and core medical services are available to all individuals identified and eligible under Title XXVI in an applicant's state, jurisdiction, or service area, as applicable. The requirements for submitting an application to waive the statutory requirement that a grantee spend at least 75 percent of its funds on core medical were previously outlined in HIV/AIDS Bureau (HAB) Policy Notice 08-02. On May 24, 2013, the Health Resources and Services Administration (HRSA) published a Final Notice with Opportunity to Comment in the Federal Register, revising HAB Policy Notice 08-02, and requesting public comment on this revised policy. This Federal Register notice seeks to address comments made by the public and to implement this policy as originally written.
``Low-Income Levels'' Used for Various Health Professions and Nursing Programs
Document Number: 2013-25275
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee
Document Number: 2013-25188
Type: Notice
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that industry organizations interested in participating in the selection of a nonvoting industry representative to represent the interests of the tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products, notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancy effective with this notice. Elsewhere in this issue of the Federal Register, FDA is publishing a separate document announcing the Request for Notification for Voting Members on the Tobacco Products Scientific Advisory Committee.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-25187
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0162, which expires on January 31, 2014. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-25184
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0025, scheduled to expire on October 31, 2013. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin; Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
Document Number: 2013-25172
Type: Rule
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of sponsorship for an ANADA.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-25171
Type: Notice
Date: 2013-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Availability of Interaction Profile for Chlorinated Dibenzo-p -Dioxins, Polybrominated Diphenol Ethers, and Phthalates
Document Number: 2013-25145
Type: Notice
Date: 2013-10-25
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services announces the availability of the interaction profile for Chlorinated Dibenzo-p- Dioxins, Polybrominated Diphenol Ethers, and Phthalates. This interaction profile evaluates a mixture of chemicals often found in human blood, adipose tissue, and breast milk. The purpose of this interaction profile is to investigate the possible joint actions of these chemicals on endocrine, developmental, and neurobehavioral endpoints in humans. This interaction profile has undergone external peer-review and review by ATSDR's Interagency Workgroup on Mixtures.
Submission for OMB Review; Comment Request
Document Number: 2013-25128
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Administration for Children and Families
Clinical Investigator Training Course
Document Number: 2013-25127
Type: Notice
Date: 2013-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-25093
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0937-0191, which expired on May 31, 2011. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-25059
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25058
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25057
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2013-25056
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2013-25055
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-25054
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-25053
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2013-25052
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services
National Institute on Deafness and Other Communication Disorders; Amended Notice of Meeting
Document Number: 2013-25039
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders, Amended Notice of Meeting
Document Number: 2013-25038
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-25035
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-25034
Type: Notice
Date: 2013-10-25
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: 2013-25033
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2013-25032
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-25031
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-25030
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-25029
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-25028
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health Notice of Meeting
Document Number: 2013-25027
Type: Notice
Date: 2013-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Home Health Agency (HHA) Accreditation Program
Document Number: 2013-25010
Type: Notice
Date: 2013-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for Home Health Agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
Document Number: 2013-25008
Type: Notice
Date: 2013-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS for ``reasonable and necessary'' determinations under Medicare. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We wish to ensure adequate representation of the interests of both women and men, members of all ethnic groups and physically challenged individuals. Therefore, we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, technology assessments, and hears public testimony on the evidence available to address the impact of medical items and services on health outcomes of Medicare beneficiaries.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-24941
Type: Notice
Date: 2013-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services