Department of Health and Human Services November 2016 – Federal Register Recent Federal Regulation Documents

Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-28798
Type: Notice
Date: 2016-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project entitled ``Knowledge, Attitudes, and Practices related to a Domestic Readiness Initiative on Zika Virus Disease.'' This project consists of telephone interviews with participants in Puerto Rico and the domestic U.S.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-28797
Type: Notice
Date: 2016-11-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Allotment Percentages to States for Child Welfare Services State Grants
Document Number: 2016-28770
Type: Notice
Date: 2016-11-30
Agency: Department of Health and Human Services, Administration for Children and Families
As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department of Health and Human Services is publishing the allotment percentage for each state under the title IV-B subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the federal grants awarded under the program.
Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
Document Number: 2016-28754
Type: Rule
Date: 2016-11-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG.
Medicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP
Document Number: 2016-27848
Type: Proposed Rule
Date: 2016-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule proposes to implement provisions of the Medicaid statute pertaining to Medicaid eligibility and appeals. This proposed rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act.
Medicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP
Document Number: 2016-27844
Type: Rule
Date: 2016-11-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements provisions of the Affordable Care Act that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, CHIP, and Exchanges. This rule finalizes most of the remaining provisions from the ``Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Proposed Rule'' that we published in the January 22, 2013, Federal Register. This final rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Superimposed Text in Direct-to-Consumer Promotion of Prescription Drugs
Document Number: 2016-28733
Type: Notice
Date: 2016-11-29
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.
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
Document Number: 2016-28732
Type: Notice
Date: 2016-11-29
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 found in FDA's ``Guidance for Industry: Expedited Programs for Serious ConditionsDrugs and Biologics.''
Meeting of the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2016-28723
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place. This meeting will be open to the public.
Prospective Grant of Exclusive Patent License: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for the Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol Dependence
Document Number: 2016-28698
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Braeburn Pharmaceuticals, Inc. (``Braeburn'') located in Princeton, New Jersey to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-28678
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-28665
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals; Establishing Appropriate Durations of Therapeutic Administration; Extension of Comment Period
Document Number: 2016-28660
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for a notice that appeared in the Federal Register of September 14, 2016. In that notice, FDA requested comments regarding the establishment of appropriately targeted durations of use of antimicrobial drugs of importance to human medicine (i.e., medically important antimicrobial drugs) when they are administered in the feed or water of food-producing animals for therapeutic purposes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Novus International, Inc.; Filing of Food Additive Petition (Animal Use); Correction
Document Number: 2016-28656
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Novus International, Inc.; Filing of Food Additive Petition (Animal Use)'' that appeared in the Federal Register of November 8, 2016 (81 FR 78528). The document announced that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2-vinylpyridine-co- styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food. The document was published with the incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Abbreviated New Drug Applications and 505(b)(2) Applications
Document Number: 2016-28655
Type: Notice
Date: 2016-11-29
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 ``Abbreviated New Drug Applications and 505(b)(2) Applications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; NUWIQ
Document Number: 2016-28654
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for NUWIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; IXINITY
Document Number: 2016-28653
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IXINITY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Document Number: 2016-28643
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-28641
Type: Notice
Date: 2016-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-28626
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2016-28625
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing and Collaboration
Document Number: 2016-28624
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.
Center for Scientific Review Notice of Closed Meetings
Document Number: 2016-28623
Type: Notice
Date: 2016-11-29
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date
Document Number: 2016-28607
Type: Rule
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is confirming the effective date of December 1, 2016, for the final rule that appeared in the Federal Register of August 24, 2016. The direct final rule amends the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This document confirms the effective date of the direct final rule.
Providing Postmarketing Periodic Safety Reports in the International Council for Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Guidance for Industry; Availability
Document Number: 2016-28606
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Council for Harmonisation (ICH) (formerly International Conference on Harmonisation) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. Periodic adverse drug experience report (PADER), or U.S. Periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of Meeting
Document Number: 2016-28605
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-28604
Type: Notice
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' Flexible gastrointestinal endoscopes and accessories are class II devices and identified with product codes such as FDF, FDS, and OCX. When using these devices during an entire day of procedures (e.g., colonoscopies), clinicians typically use one irrigation system (i.e., one water bottle, one set of tubing and valves, etc.) without cleaning and sterilizing all the system components between patients. This guidance highlights the cross-contamination risk associated with day-use of irrigation systems used with flexible gastrointestinal endoscopes; clarifies terminology used to describe these devices; and outlines strategies to mitigate the risk of cross-contamination between patients during these procedures.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-28588
Type: Notice
Date: 2016-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
Document Number: 2016-28582
Type: Rule
Date: 2016-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget
Document Number: 2016-28569
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Announcement of Requirements and Registration for “Storytelling About Health and Wellness in American Indian and Alaska Native Communities” Challenge
Document Number: 2016-28497
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
In recognition of Native American Heritage Month, the Tribal Health Research Office in the Division of Program Coordination, Planning, and Strategic Initiatives, in the Office of the Director of the National Institutes of Health (NIH), announces the ``Storytelling about Health and Wellness in American Indian and Alaska Native Communities'' Challenge. The goal of this Challenge is to develop a brief digital story (i.e., a video) that communicates how traditions and heritage promote health in American Indians and Alaska Natives (AI/ AN).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28496
Type: Notice
Date: 2016-11-28
Agency: Substance Abuse and Mental Health Services Administration, Department of Health and Human Services
Decision To Evaluate a Petition To Designate a Class of Employees From Metals & Controls Corp. in Attleboro, Massachusetts, To Be Included in the Special Exposure Cohort
Document Number: 2016-28480
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Metals & Controls Corp. in Attleboro, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-28470
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2016-28469
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that a meeting is scheduled for Advisory Committee on Interdisciplinary, Community- Based Linkages (ACICBL). This meeting will be open to the public. Information about the ACICBL and the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/ advisorycommittees/bhpradvisory/acicbl/index.html. The agenda will be available 2 days prior to the meeting on the HRSA Web site listed above.
Notice of Listing of Members of the Food and Drug Administration's Performance Review Board
Document Number: 2016-28452
Type: Notice
Date: 2016-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42 SES Equivalents performance appraisals, bonus recommendations, and pay adjustments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
Document Number: 2016-28443
Type: Notice
Date: 2016-11-28
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.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Document Number: 2016-28442
Type: Notice
Date: 2016-11-28
Agency: Food and Drug Administration, Department of Health and Human Services
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report containing additional information and analyses on the status of PMRs and PMCs is available on FDA's Web site.\1\
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28434
Type: Notice
Date: 2016-11-28
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: 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-28433
Type: Notice
Date: 2016-11-28
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-28431
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-28417
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28416
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2016-28415
Type: Notice
Date: 2016-11-28
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guideline Update-CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections
Document Number: 2016-28385
Type: Notice
Date: 2016-11-25
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 the opening of a docket to obtain public comment on the Draft Update of CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections (Draft Recommendation Update). The Draft Recommendation Update addresses new and updated strategies for the prevention of intravascular catheter- related infections in healthcare settings. CDC is providing a supporting appendix in the docket that includes primary evidence, study evaluation, and data evaluation tables that were used in developing the Draft Recommendation Update.
Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability
Document Number: 2016-28334
Type: Notice
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules.
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2016-28333
Type: Rule
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments
Document Number: 2016-28332
Type: Notice
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Submission of Quality Metrics Data.'' In order to help develop compliance and inspection policies and practices, improve the Agency's ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing, FDA intends to initiate a quality metrics reporting program. The revised draft guidance describes FDA's plans for an initial, voluntary phase of this program. FDA expects that this voluntary phase will allow the Agency to learn more about a limited set of quality metrics and associated analytics, and to help inform future FDA decisionmaking about its quality metrics program. This revised draft also provides an opportunity to gain additional perspectives from industry participants on the future use of quality metrics data.
Request for Nominations on the Blood Products Advisory Committee
Document Number: 2016-28306
Type: Notice
Date: 2016-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2016-28303
Type: Notice
Date: 2016-11-25
Agency: Department of Health and Human Services, National Institutes of Health