Department of Health and Human Services June 2013 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 284
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-14209
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2013-14208
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-14207
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-14206
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-14205
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-14204
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Alzheimer's Disease Supportive Services Program-Data Reporting Tool
Document Number: 2013-14189
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services
The Administration on Aging (AoA), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 collects comments on the information collection requirements relating to the continuation of an existing collection for the Alzheimer's Disease Supportive Services Program.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-14181
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Open Meeting
Document Number: 2013-14172
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a research institute of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS), will hold a scientific meeting titled ``Novel Phenotyping Methods in Symptoms of Lower Urinary Tract Dysfunction'' and invites the public to attend.
National Institute for Occupational Safety and Health (NIOSH) Traumatic Injury Research and Prevention Program and Strategic Goals; Draft Document Availability
Document Number: 2013-14133
Type: Notice
Date: 2013-06-17
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of a draft document entitled National Institute for Occupational Safety and Health (NIOSH) Traumatic Injury Research and Prevention Program and Strategic Goals now available for public comment. To view the notice and related materials, visit http:// www.regulations.gov and enter CDC-2013-0009 in the search field and click ``Search.'' Public comment period: Comments must be received September 16, 2013 from publication of the Federal Register Notice.
Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability
Document Number: 2013-14097
Type: Notice
Date: 2013-06-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013. The draft guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution. The guidance document is intended to assist manufacturers obtain a biologics license. The guidance contains information about the manufacture of minimally manipulated, unrelated allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements. The draft guidance, when finalized, is intended to supersede the guidance entitled ``Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated October 2009.
Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System; Availability
Document Number: 2013-14096
Type: Notice
Date: 2013-06-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013. The draft guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an Investigational New Drug Application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. If unlicensed HPC, Cord Blood units are made available for clinical use, they must be distributed under an IND. The draft guidance, when finalized, is intended to supersede the document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications'' dated June 2011.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-14174
Type: Notice
Date: 2013-06-14
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 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.
Proposed Collection; Comment Request: Palliative Care: Conversations Matter Evaluation
Document Number: 2013-14173
Type: Notice
Date: 2013-06-14
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 Institute of Nursing Research (NINR), the 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 obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.
Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination; Availability
Document Number: 2013-14168
Type: Notice
Date: 2013-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The FDA is announcing the availability of a guidance for industry entitled ``Codevelopment of Two or More New Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more investigational drugs that have not been previously developed for any indication (i.e., ``new investigational drugs'') to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during codevelopment of two or more new investigational drugs. It is not intended to apply to development of combinations of already approved drugs or to development of a single new investigational drug to be used in combination with an already approved drug or drugs. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-14167
Type: Notice
Date: 2013-06-14
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 of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices in order to maintain information confidentiality, integrity, and availability. This draft guidance is not final nor is it in effect at this time.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2013-14165
Type: Notice
Date: 2013-06-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-14156
Type: Notice
Date: 2013-06-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-14152
Type: Notice
Date: 2013-06-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute for Occupational Health (NIOSH)-Certified B Readers; Training and Testing
Document Number: 2013-14147
Type: Notice
Date: 2013-06-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC, is requesting information from stakeholders and the general public to identify and prioritize competencies currently needed by B Readers. The information obtained will be used in the development of the new digital B Reader program, including training and examinations.
Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2013-14137
Type: Notice
Date: 2013-06-14
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 ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document was initially issued in draft on November 10, 2011, and was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. The guidance was also intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. This guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to specify certain situations in which FDA cannot disapprove an IDE. This draft guidance is not final nor is it in effect at this time.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-14129
Type: Notice
Date: 2013-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-14128
Type: Notice
Date: 2013-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2013-14127
Type: Notice
Date: 2013-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-14126
Type: Notice
Date: 2013-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities Research Endowments
Document Number: 2013-13991
Type: Proposed Rule
Date: 2013-06-14
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) proposes to issue regulations governing National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and section 464z-4 Centers of Excellence to facilitate minority health disparities research and other health disparities research.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-14037
Type: Notice
Date: 2013-06-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive License: Modulation of Poliovirus Replicative Fitness by Deoptimization of Synonymous Codons
Document Number: 2013-14036
Type: Notice
Date: 2013-06-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is considering granting an exclusive license, in the field of use of vaccine targets for treatment or prevention of diseases in human health and in animal health, to practice the inventions listed in the patent applications referred to below to Codagenix Inc., having a place of business in Stony Brook, New York. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: 2013-13997
Type: Notice
Date: 2013-06-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2013-13996
Type: Notice
Date: 2013-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for OMB Review; Comment Request
Document Number: 2013-13947
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Discretionary Grant Program
Document Number: 2013-13941
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will be issuing non-competitive awards under the Family- to-Family Health Information Centers Program. Approximately $4.9M will be made available in the form of a grant to current grantees (see below) during the budget period of 6/1/20135/31/2014. This will provide for an extension of the program for one year, as provided for in section 624 of the American Taxpayer Relief Act of 2012 (Pub. L. 112-240) (ATRA) with the least disruption to the states, communities, and constituencies that currently receive assistance and services from these grantees.
Orphan Drug Regulations
Document Number: 2013-13930
Type: Rule
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-13929
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
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
Document Number: 2013-13923
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
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; Proposed Collection; Public Comment Request
Document Number: 2013-13918
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-13915
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2013-13905
Type: Notice
Date: 2013-06-12
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; Proposed Collection; Comment Request: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Document Number: 2013-13904
Type: Notice
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection resulting from investigational new drug (IND) safety reporting requirements and safety reporting requirements for bioavailability and bioequivalence studies.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-13899
Type: Notice
Date: 2013-06-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567
Document Number: 2013-13896
Type: Notice
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Forms FDA 356h and 2567.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-13895
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Mental Health; Notice of Meeting
Document Number: 2013-13894
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2013-13893
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-13892
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-13891
Type: Notice
Date: 2013-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Establishing a List of Qualifying Pathogens Under the Food and Drug Administration Safety and Innovation Act
Document Number: 2013-13865
Type: Proposed Rule
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is proposing a regulation to establish a list of ``qualifying pathogens'' that have the potential to pose a serious threat to public health. The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. FDA is proposing that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule describes the factors we considered and the methodology we used to develop this list of qualifying pathogens.
Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs
Document Number: 2013-13864
Type: Proposed Rule
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify stair-climbing wheelchairs, a class III device, into class II (special controls) based on new information and subject to premarket notification, and to further clarify the identification.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
Document Number: 2013-13858
Type: Notice
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
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 procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (Form FDA 3671).
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments
Document Number: 2013-13857
Type: Rule
Date: 2013-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. This action is in response to a petition filed by E. & J. Gallo Winery.