Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 284
Announcement of the Award of Single-Source Expansion Supplement Grants to Eight Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS) announces the award of single-source expansion supplement grants to eight PREIS grantees for the purpose of expanding program participation and/or sites to support the increase of data necessary to determine the level of program effectiveness. In FY 2010, FYSB awarded 13 cooperative agreement grants under Funding Opportunity Announcement (FOA) number: OPHS/OAH/TPP PREP Tier 2-2010. Under this FOA, a total of $9.7 million was made available on a competitive basis to implement and test innovative strategies. Single-source program expansion supplement awards are made to the following PREIS grantees:
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 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 0990-0275 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.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.
Cooperative Agreement To Support the Western Center for Food Safety
The Food and Drug Administration (FDA) is announcing the availability of grant funds for a cooperative agreement to support the Western Center for Food Safety (WCFS). FDA regards the continued support of WCFS as crucial to receiving invaluable insight into the food safety issues that it is directed to address through various provisions of the FDA Food Safety Modernization Act (FSMA). FDA concludes this partnership will enhance FDA's efforts to address the particularly complex issues surrounding the safety of agricultural production. Partnering with WCFS provides FDA with the opportunity to stimulate collaborations so that resources can be leveraged to maximize food safety research, education, and outreach efforts aimed at WCFS and FDA stakeholders particularly those within the agricultural community. A key outcome of this effort is to enhance FDA's implementation of the prevention oriented activities outlined in FSMA.
Prospective Grant of Exclusive License: Start-Up Commercial License for the Development of Fenoterol and Fenoterol Analogues for the Treatment of Brain, Liver, and Pancreatic Cancers and Congestive Heart Failure
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Mitchell Woods Pharmaceuticals, LLC, of an exclusive commercialization license to practice the inventions embodied in the following U.S. Patent Applications (and all continuing applications and foreign counterparts): Serial No. 61/651,961, filed May 25, 2012, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Reference E-139-2012/0-US-1]; Serial No. 61/ 789,629, filed March 15, 2013, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Reference E-139-2012/1-US-1]; Serial No. 61/312,642, filed March 10, 2010, entitled, ``The Use of Fenoterol and Fenoterol Analogues in the Treatment of Glioblastomas and Astrocytomas'' [HHS Reference E-013- 2010/0-US-01]; Serial No. 60/837,161, filed August 10, 2006, entitled, ``Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure'' [HHS Reference E-205-2006/0-US-1]; and Serial No. 60/927,825, filed May 3, 2007, entitled ``Preparation of R,R-Fenoterol and R,R-Fenoterol Analogues and Their Use in Congestive Heart Failure'' [HHS Reference E-205-2006/1-US-1]. The patent rights in these inventions have been assigned or exclusively licensed to the Government of the United States of America. The prospective exclusive commercialization license territory may be worldwide, and the scope may be limited to the following two fields of use:
Proposed Collection; 60-Day Comment Request; Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI)
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 Cancer Institute (NCI), 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 on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Sarah Kobrin, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., MSC 9761, Rockville, MD 20852, or call non-toll- free number 240-276-6931 or Email your request, including your address to: kobrins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Awareness and Beliefs about Cancer Survey, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The objective of the study is gather data about American adults' awareness and beliefs about cancer. The ultimate goal is to determine how individuals' perceptions of cancer may influence their decisions to report signs and symptoms to health care providers, perhaps affecting the disease stage of diagnosis and the effectiveness of treatment. Data will be collected from approximately 2,000 adults aged 50 years or older across the United States for the NCI Awareness and Beliefs about Cancer survey over a one-year period. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,334.
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 Office of the Assistant Secretary for Planning and Evaluation (ASPE), 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 a new collection. 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.
Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop
The Food and Drug Administration (FDA), the Cardiac Safety Research Consortium, and the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) will cosponsor a public workshop entitled ``Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study.'' The workshop will introduce for discussion a new nonclinical paradigm for assessing Torsade de Pointes (TdP) risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop, which will seek input from all attendees, is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the United States, the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. Date and Time: The public workshop will be held on July 23, 2013, from 8 a.m. to 6 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Contact Person: Devi Kozeli, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4183, Silver Spring, MD 20993, 301-796-1128, email: devi.kozeli@fda.hhs.gov. SUPPLEMENTARY INFORMATION: This workshop will introduce for discussion a new nonclinical paradigm for assessing TdP risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop, which will seek input from all attendees, is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the United States, the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. A description of the planned activities for the workshop can be found at: https://www.hesiglobal.org/i4a/pages/index.cfm?pageID=3620 (FDA has verified this online address but is not responsible for subsequent changes to the Web site where it is located after this document publishes in the Federal Register.) Registration and Accommodations: Registration for non-FDA attendees should be performed online at the following address: https:// evm.auxserv.duke.edu/iebms/reg/regp1 form.aspx?oc=10&ct=DCRIHBD09&eventid=50715. (FDA has verified this online address but is not responsible for subsequent changes to the Web site where it is located after this document publishes in the Federal Register.) Registration for FDA attendees is also online, at the following address: https://duke.qualtrics.com/SE/?SID=SVbmv7T8GPm4IAPd3. The registration deadline for paying attendees is July 15, 2013. With the exception of FDA employees and a limited number of speakers or organizers, registrants must pay a registration fee covering the cost of facilities, materials, and food. The registration fees for different categories of attendee are as follows:
Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source award to the University of North Carolina. The goal of the award is to identify what component(s) of the complex heparin mixtures have the propensity to cause heparin induced thrombocytopenia (HIT) to improve the safety of heparin drug products. The FDA seeks to identify the components of the heparin mixture that are associated with HIT so that actions may be taken to reduce these events and improve patient outcomes with this widely used drug.
Survey of Nanomaterial Risk Management Practices
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting and opportunity for comment on a proposed NIOSH survey. The primary purpose of the survey is to evaluate the use of NIOSH guidelines and risk mitigation practices for safe handling of engineered nanomaterials (ENMs) in the workplace. Information collected from the survey will be useful in future revisions of the guidelines. The public is invited to comment on the proposed survey through a public docket and/or participation in a one-day public meeting. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2013-0010 in the search field and click ``Search.'' Public comment period: Submit either electronic or written comments by September 15, 2013. Registration to attend the meeting must be received by July 17, 2013 and will be accepted on a first come first served basis. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting.
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify intra-aortic balloon and control system devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for intra-aortic balloon and control systems when indicated for septic shock or pulsatile flow generation. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements when indicated for septic shock or pulsatile flow generation. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis
The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's implementation of Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA), which provides FDA with important new authorities to help it better protect the integrity of the drug supply chain. In addition to providing a general overview of Title VII and FDA's approach to implementing these provisions, the meeting will give interested persons an opportunity to provide input that will assist FDA in the development of regulations implementing two sections of Title VII, which relate to standards for admission of imported drugs and commercial drug importers. Specifically, FDA is seeking information on the types of information that importers should be required to provide under Title VII as a condition of admission. FDA is also seeking information regarding registration requirements for commercial drug importers and good importer practices to be established under Title VII.
Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, Premium Stabilization Programs, and Market Standards
This proposed rule sets forth financial integrity and oversight standards with respect to Affordable Insurance Exchanges; Qualified Health Plan (QHP) issuers in Federally-facilitated Exchanges (FFEs); and States with regard to the operation of risk adjustment and reinsurance programs. It also proposes additional standards with respect to agents and brokers. These standards, which include financial integrity provisions and protections against fraud and abuse, are 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.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Brookhaven National Laboratory in Upton, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). On June 7, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
State Long-Term Care Ombudsman Program
The Administration on Aging (AoA) of the Administration for Community Living (ACL) within the Department of Health and Human Services (HHS) is issuing a Notice of Proposed Rulemaking, with request for comments, to implement provisions of the Older Americans Act, the State Long-Term Care Ombudsman program. This proposed rule replaces AoA's 1994 Notice of Proposed Rulemaking. Since 1992, the functions of this program have been delineated in the Older Americans Act; however, regulations have not been promulgated for any Title VII program. In the absence of regulatory guidance, there has been significant variation in the interpretation and implementation of these provisions among States. Recent inquiries from States and an AoA compliance review in one State have highlighted the difficulty of determining State compliance in carrying out the Long-Term Care Ombudsman program functions. This rulemaking provides the first regulatory guidance for States' Long-Term Care Ombudsman programs to provide clarity about implementation. HHS estimates that a number of states may need to update their statutes, regulations, policies and/or practices in order to operate the program consistent with federal law and this proposed regulation. The effective date of the rule is anticipated to be one year after publication of any final rule to allow States appropriate time for such changes, if needed. AoA anticipates little or no financial impact on the providers of long-term care ombudsman services, the consumers served by the program, or long-term care providers through implementation of the proposed rules. AoA believes that consumers (particularly residents of long-term care facilities) and long-term care providers will benefit from the implementation of these proposed rules. Consumers and other complainants across the country will receive services from the Long- Term Care Ombudsman program with less variation in the quality, efficiency, and consistency of service delivery. Long-term care ombudsmen and States will also benefit from the implementation of these proposed rules in the establishment and operation of the Long-Term Care Ombudsman program at the State and local levels. For years, States and long-term care ombudsmen at every level have reported to AoA that they have found some provisions of the Act confusing to implement. The proposed rule seeks to provide the clarity that program stakeholders have requested.
Meeting of the National Biodefense Science Board
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting via teleconference. This notice is being published under exceptional circumstances and provides the reason for providing less than 15 calendar days notice. The meeting is open to the public.
Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements
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 reporting requirements for submission and listing of patent information associated with a new drug application (NDA), an amendment, or a supplement.
Indian Self-Determination and Education Assistance Contracts; Correction
The Indian Health Service published a document in the Federal Register on May 30, 2013, concerning a request for a renewal of the collection of information, titled, ``Indian Self Determination and Education Assistance Contracts, 25 CFR Part 900.'' The document contained an error regarding the ``Estimated Time per Response.''
Request for Public Comment: 60-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
In compliance with Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60-days advance opportunity 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: 0917-0006, ``Application for Participation in the IHS Scholarship Program.'' Type of Information Collection Request: Three year extension of the currently approved information collection, 0917-0006, ``Application for Participation in the IHS Scholarship Program.'' Form Number(s): IHS-856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS-817, and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current Information Collection Request. Reporting forms are found on the IHS Web site at www.ihs.gov/scholarship. Form Numbers: IHS-856, IHS-856-2, IHS-856-4, IHS-856-20, IHS-815, and IHS-816 have been deleted from the previous Information Collection Request in an effort to comply with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to: solicit, process, and award IHS Pre-graduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHS Scholarship Program streamlined the application process by converting the IHS-856 to an electronic tool and reduced the number of required supplemental application and reporting forms to minimize the time needed by applicants and recipients to complete the application process and provide required information after receiving a scholarship from the IHSSP. The IHSSP application is electronically available on the internet at the IHS Web site at: https://www.ihs.gov/ scholarship/apply_now.cfm. Affected Public: Individuals, not-for-profit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for a revision of an approved collection of information titled, ``Indian Health Service Medical Staff Credentials and Privileges Files,'' OMB Control Number 0917-0009, which expires June 31, 3013. This proposed information collection project was previously published in the Federal Register (78 FR 19721) on April 2, 2013, and allowed 60 days for public comment, as required by 3506(c)(2)(A). The IHS received one comment concerning the ``Optometric Privileges Request Form'' in regards to the defining of physicians and optometrists separately. The IHS responded that it will not include the ``Optometric Privileges Request Form'' for consideration in this requestpending a review of ways to enhance the quality, utility and clarity of this particular form. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Type of Information Collection Request: Revision of an approved information collection, 0917-0009, ``Indian Health Service Medical Staff Credentials and Privileges Files.'' Form Numbers: 0917-0009. Need and Use of Information Collection: This collection of information is used to evaluate individual health care providers applying for medical staff privileges at IHS health care facilities. The IHS operates health care facilities that provide health care services to American Indians and Alaska Natives. To provide these services, the IHS employs (directly and under contract) several categories of health care providers including: Physicians (M.D. and D.O.), dentists, psychologists, optometrists, podiatrists, audiologists, physician assistants, certified registered nurse anesthetists, nurse practitioners, and certified nurse midwives. IHS policy specifically requires physicians and dentists to be members of the health care facility medical staff where they practice. Health care providers become medical staff members, depending on the local health care facility's capabilities and medical staff bylaws. There are three types of IHS medical staff applicants: (1) Health care providers applying for direct employment with IHS; (2) contractors who will not seek to become IHS employees; and (3) employed IHS health care providers who seek to transfer between IHS health care facilities. National health care standards developed by the Centers for Medicare and Medicaid Services, the Joint Commission, and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves. In addition to the initial granting of medical staff membership and clinical privileges, the Joint Commission standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty. The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is a Joint Commission requirement. Prior to the establishment of this Joint Commission requirement, the degree to which medical staff applications were maintained at all health care facilities in the United States that are verified for completeness and accuracy varied greatly across the Nation. The application process has been streamlined and is using information technology to make the application electronically available on the Internet. The application may be found at the IHS.gov Web site address: https://www.ihs.gov/IHM/index.cfm?module=dspihmpcp3c1 ex#Manual Exhibit 3-1-A. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of annual number of responses, Average burden per response, and Total annual burden hours.
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