Department of Health and Human Services August 1, 2013 – Federal Register Recent Federal Regulation Documents
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Request for Information Regarding Nondiscrimination in Certain Health Programs or Activities
Section 1557 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) (42 U.S.C. 18116) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the Affordable Care Act authorizes the Secretary of the Department of Health and Human Services (Department) to promulgate regulations to implement the nondiscrimination requirements in Section 1557. This notice is a request for information (RFI) to inform the Department's rulemaking for Section 1557. This RFI seeks information on a variety of issues to better understand individuals' experiences with discrimination in health programs or activities and covered entities' experiences in complying with Federal civil rights laws.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
HHS is soliciting nominations for six non-Federal members of the Advisory Council on Alzheimer's Research, Care, and Services. The six positions are for each of the following categories, as specified in the National Alzheimer's Project Act: Alzheimer's patient advocate, Alzheimer's caregiver, health care provider, representative of state health department, researcher with Alzheimer's-related expertise, and voluntary health association representative. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Solicitation of Written Comments on the Draft Report of the National Adult Immunization Standards of Practice for Consideration by the National Vaccine Advisory Committee
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The ASH has charged the NVAC with examining the current adult immunization environment by updating adult immunization standards of practice with the intention of ultimately impacting Healthy People 2020 goals. A review group was established to address this charge on behalf of the NVAC. Through discussion and careful review, the group has developed draft recommendations for consideration by the NVAC to achieve this charge. It is anticipated that the draft report, as revised with consideration given to public comment and stakeholder input, will be presented in at the NVAC at the September 2013 meeting for deliberation and decision on their final recommendation. The draft report will be made available for public review and written comment.
Solicitation of Written Comments on the Global Immunizations Working Group's Draft Report and Draft Recommendations for Enhancing the Work of the HHS National Vaccine Program in Global Immunizations for Consideration by the National Vaccine Advisory Committee
The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The ASH charged the NVAC with reviewing the role of HHS in global vaccination, the effects of global vaccination on global populations, the effects of global vaccination on U.S. populations, and recommending how HHS can best continue to contribute, consistent with its newly established Global Health Strategy and Goal 5 of the National Vaccine Plan. The NVAC was also asked to make recommendations on how to best communicate this information to decision makers and the general public to ensure continued sufficient resources for the global vaccination efforts. The NVAC established the Global Immunizations Working Group to assist in addressing these charges. A draft report and draft recommendations have been developed by the working group for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in September 2013 at the quarterly NVAC meeting.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the Annual Report submitted to the Secretary and Congress by the contracted consensus-based entity (CBE) as mandated by section 1890(b)(5) of the Social Security Act, as created by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills those requirements.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
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 revision of a previously-approved information collection assigned OMB control number 0937-0025, which expired on 08/31/2013. 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.
Prospective Grant of Start-up Exclusive License: Kits for the Detection of Human Interferon-Alpha Subtypes and Allotypes
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to practice the inventions embodied in: US provisional application No. 61/116,563, filed November 20, 2008, PCT application No. PCT/US2009/65382, filed November 20, 2009; and corresponding National Phase filings in the US, EP, AU, CA, IL, JP and HK (NIH Ref. E-157-2008/0), titled ``Compositions for Detecting Human Interferon- Alpha Subtypes and Methods of Use'', to IES Diagnostics, LLC having a place of business at 12 Upper Drive, Watchung, NJ 07069. The patent rights in these inventions have been assigned to the United States of America.
Prospective Grant of Start-up Exclusive License: Topical Antibiotic With Immune Stimulating Oligodeoxynucleotide Molecules To Speed Wound Healing; and Use of CpG Oligodeoxynucleotides To Induce Epithelial Cell Growth
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to practice the inventions embodied in: US provisional Applications 61/639,688 (E-294-2011/0-US-01) filed April 27, 2012 and PCT application PCT/US2013034639 (E-294-2011/0-PCT-02) filed March 29, 2013, each entitled ``Topical Antibiotic with Immune Stimulating oligodeoxynucleotide Molecules to Speed Wound Healing'' and US application 12/205,756 (E-328-2001/1-US-01) filed September 2008 and issued as US patent 8,466,116, each entitled ``Use of CpG Oligodeoxynucleotides to Induce Epithelial Cell Growth'' to Tollgene having a place of business at 2429 Ginny Way, Lafayette, CO 80026. The patent rights in these inventions have been assigned to the United States of America.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2013 (FY 2014)
This notice updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2013 through September 30, 2014.
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