Department of Health and Human Services July 2014 – Federal Register Recent Federal Regulation Documents

Fees for Sanitation Inspections of Cruise Ships
Document Number: 2014-17981
Type: Notice
Date: 2014-07-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2015. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection.
New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
Document Number: 2014-17912
Type: Rule
Date: 2014-07-31
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 June 2014. 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 remove a cross-reference to a combination drug medicated feed that is no longer codified.
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2014-17971
Type: Notice
Date: 2014-07-30
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 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR Part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1187 to include account registration elements associated with submitting data through the Amazon Cloud EDGE Server or the On-Premise EDGE server. As a result of contractor changes and technical design changes to our distributed data collection (DDC) approach for implementing the risk adjustment and reinsurance programs, we must change the data elements that issuers will submit as part of the DDC information collection requirements. These modifications will permit us to register EDGE servers with the appropriate issuer accounts, permitting CMS to make risk adjustment and reinsurance payments to issuers.
Proposed Collection; 60-Day Comment Request; The NIH/NCATS GRDRSM
Document Number: 2014-17952
Type: Notice
Date: 2014-07-30
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 Center for Advancing Translational Sciences (NCATS), 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 instuments, submit comments in writing, or request more information on the proposed project, contact Yaffa Rubinstein, Ph.D., Office of Rare Diseases Research (ORDR), National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), 6701 Democracy Boulevard, Room 1004, Bethesda, Maryland 20892, or call non-toll free number (301) 402-4338, or Email your request including your address to yaffa.rubinstein@nih.gov. Formal requests for additional plans and instuments 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: The NIH/NCATS GRDR\SM\ Program, 0925-NEW GRDR, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH). Need and Use of Information Collection: The NIH created the GRDR program https://grdr.ncats.nih.gov an informatics system and central data repository, housed at the NCATS/NIH Center to support and accelerate research in the cause, diagnosis, and treatment of rare diseases. The GRDR program collects a wide range of data types, including phenotypic, clinical, and genomic, as well as medical images, derived from individuals who participate in rare disease patient registries, regardless of the source of funding. The GRDR program provides the infrastructure to store, search across, retrieve, and analyze these varied types of data. This valuable information will help NIH understand and evaluate the use of repositories/datasets in the research community. The GRDR program will support: (1) Mapping data to standards; (2) increased visibility for participating registries; (3) opportunity for cross-disease research; (4) better and faster RD clinical research. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 100.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Correcting Amendment
Document Number: 2014-17937
Type: Rule
Date: 2014-07-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the final rule that appeared in the August 19, 2013 Federal Register, entitled ``Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-17936
Type: Notice
Date: 2014-07-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Care Coordination Quality Measure for Patients in the Primary Care Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Medical Device User Fee Rates for Fiscal Year 2015
Document Number: 2014-17902
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2015, which apply from October 1, 2014, through September 30, 2015. To avoid delay in the review of your application, you should pay the standard fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2015, you should not submit a FY 2015 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2015 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Guidance for Industry and Food and Drug Administration Staff
Document Number: 2014-17901
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This document provides CDRH's interpretation of key provisions of section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as these provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-17898
Type: Notice
Date: 2014-07-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Safety Communication Readership Survey
Document Number: 2014-17891
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``FDA Safety Communication Readership Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2014-17890
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
Findings of Research Misconduct
Document Number: 2014-17889
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhihua Zou, Ph.D., Harvard Medical School and Fred Hutchinson Cancer Research Center: Based on the reports of investigations conducted by Harvard Medical School (HMS) and Fred Hutchinson Cancer Research Center (FHCRC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhihua Zou, former Postdoctoral Fellow, Department of Neurobiology, HMS, and former Staff Scientist, Division of Basic Sciences, FHCRC, engaged in research misconduct in research supported by National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), grants R01 DC001622 and R01 DC004842. ORI found that Respondent engaged in research misconduct by falsifying data that were included in two (2) publications:
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2014-17861
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2014-17860
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-17859
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-17840
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2014-17839
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2014-17838
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Hearing: Reconsideration of Disapproval; Louisiana Medicaid State Plan Amendments (SPAs) 13-23, 13-25 and 13-28
Document Number: 2014-17871
Type: Notice
Date: 2014-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on September 9, 2014, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health, Dallas Regional Office, 1301 Young Street, Room 801, 8th Floor Dallas, Texas 75202 to reconsider CMS' decision to disapprove Louisiana's Medicaid SPAs 13-23, 13-25 and 13-28. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by August 13, 2014.
Medicare Program; Expanded Medicare Prior Authorization for Power Mobility Devices (PMDs) Demonstration
Document Number: 2014-17805
Type: Notice
Date: 2014-07-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the expansion of the Medicare Prior Authorization for Power Mobility Devices (PMDs) Demonstration to 12 additional states.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2014-17804
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of Tribal Self-Governance Program; Planning Cooperative Agreement
Document Number: 2014-17801
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Indian Health Service
Office of Tribal Self-Governance Program, Negotiation Cooperative Agreement
Document Number: 2014-17800
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Indian Health Service
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2014-17767
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Meetings; Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2014-17739
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Health Disparities Subcommittee (HDS)
Document Number: 2014-17737
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Advisory Committee to the Director, Centers for Disease Control and Prevention
Document Number: 2014-17736
Type: Notice
Date: 2014-07-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2014-17725
Type: Notice
Date: 2014-07-29
Agency: Department of Health and Human Services, Administration for Children and Families
Nonprescription Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-17711
Type: Notice
Date: 2014-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Nonprescription Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-17710
Type: Notice
Date: 2014-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-17660
Type: Notice
Date: 2014-07-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 23rd and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Animal Generic Drug User Fee Cover Sheet
Document Number: 2014-17712
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Generic Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket
Document Number: 2014-17691
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of ``reserving'' proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.
Notice of Kidney Interagency Coordinating Committee Meeting
Document Number: 2014-17685
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 12, 2014 about assessing public health interventions in chronic kidney disease (CKD). The meeting is open to the public.
Proposed Collection; 60-Day Comment Request; Progress Reports for Center for Global Health's Low and Mid-Income Countries; (LMICs) Global Health Collaborations
Document Number: 2014-17684
Type: Notice
Date: 2014-07-28
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 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: Teri Brown, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free number 240-276-5810 or Email your request, including your address to: brownte@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: Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Global Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health Collaborations is proposing new program specific progress report guidelines. The CGH LMIC Global Health Collaborations are part of a pilot initiative and partnership, between the NCI CGH and the Office of Cancer Centers (OCC), to promote collaborations between the NCI designated Cancer Centers and foreign institutions from Low and Middle Income Countries (LMICs). This collaboration is designed to develop and implement mutually beneficial global cancer research programs by increasing the capability of these countries to participate and partner in cancer research. The proposed guidelines request information about award performance related to objectives, accomplishments, barriers and challenges, collaborators, and findings. The information is gathered six months into the award and 12 months after the award (upon expiry). This information is needed to monitor the performance of this special program within NCI, funded through three Request for Proposals (RFPs); the first was released April 18, 2013 and CGH expects to release another in 2014 and the final one in 2015. The respondents are the Principal Investigators of the awards. The information will be used to monitor individual award performance and the effectiveness of the program as a whole. Since these projects are funded through the contract mechanism, the PIs will not be required to submit interim and final progress reports like other National Institutes of Health grantees must. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 83.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-17676
Type: Notice
Date: 2014-07-28
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: 2014-17675
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2014-17674
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2014-17673
Type: Notice
Date: 2014-07-28
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: 2014-17672
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review ;Notice of Closed Meeting
Document Number: 2014-17671
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2014-17670
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2014-17668
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-17666
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' This guidance document describes FDA's current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA's review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-17665
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2014-17664
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2014-17654
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-17651
Type: Notice
Date: 2014-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-17646
Type: Notice
Date: 2014-07-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Reports of Corrections and Removals
Document Number: 2014-17633
Type: Notice
Date: 2014-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Reports of Corrections and Removals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.