Department of Health and Human Services September 26, 2014 – Federal Register Recent Federal Regulation Documents

National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2014-23026
Type: Notice
Date: 2014-09-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-23000
Type: Notice
Date: 2014-09-26
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 a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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. Interested persons are invited to send comments regarding this 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-22990
Type: Notice
Date: 2014-09-26
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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. 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: (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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2014-22987
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
Document Number: 2014-22986
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction
Document Number: 2014-22983
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting and scientific workshop, both of which will provide an opportunity for public comment on the topic of Female Sexual Interest/ Arousal Disorder (FSIAD), the most common form of female sexual dysfunction. FSIAD is a diagnosis that combines two previously distinct disordershypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD). The public meeting will take place on October 27, 2014, and is part of FDA's Patient-Focused Drug Development performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will obtain patients' perspectives on the impact that FSIAD (or a prior diagnosis of HSDD or FSAD) has on their daily lives, as well as their perspectives on the available therapies for these conditions. The scientific workshop will take place on October 28, 2014, and will provide an opportunity for FDA to seek input from experts on scientific issues important to the clinical development of drug products intended to treat FSIAD.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
Document Number: 2014-22982
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions
Document Number: 2014-22981
Type: Notice
Date: 2014-09-26
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 ``Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-22980
Type: Notice
Date: 2014-09-26
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.
Submissions for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-22973
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' This draft guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices. This draft guidance is not final nor is it in effect at this time.
Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Reopening of the Comment Period
Document Number: 2014-22951
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance document entitled ``Informed Consent Information Sheet.'' A notice of availability requesting comments on the draft guidance document appeared in the Federal Register of July 15, 2014. The Agency is reopening the comment period to update comments and to receive any new information.
Decision To Evaluate a Petition To Designate a Class of Employees From the Idaho National Laboratory in Idaho Falls, Idaho, To Be Included in the Special Exposure Cohort
Document Number: 2014-22943
Type: Notice
Date: 2014-09-26
Agency: Department of Health and Human Services
NIOSH gives notice as required by 42 C.F.R. Sec. 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Idaho National Laboratory in Idaho Falls, Idaho, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Idaho National Laboratory. Location: Idaho Falls, Idaho. Job Titles and/or Job Duties: All employees who worked in any area. Period of Employment: January 1, 1949 through December 31, 1970.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2014-22905
Type: Notice
Date: 2014-09-26
Agency: Food and Drug Administration, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2014-22893
Type: Notice
Date: 2014-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-22892
Type: Notice
Date: 2014-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-22891
Type: Notice
Date: 2014-09-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2015
Document Number: 2014-22625
Type: Notice
Date: 2014-09-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2015. The calendar year 2015 AIC threshold amounts are $150 for ALJ hearings and $1,460 for judicial review.