82 FR 27497 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 114 (June 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 114 (June 15, 2017)
| Page Range | 27497-27501 | |
| FR Document | 2017-12352 |
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)] [Notices] [Pages 27497-27501] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-12352] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by July 17, 2017, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by July 17, 2017. Nominations will be accepted for current vacancies and for those that will or may occur through November 30, 2017. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to [email protected], by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal at: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the [[Page 27498]] selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301- 796-8220, email: [email protected]. For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1. Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory Research, Food and Drug Administration, Committee. 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993-0002, phone: 301-796-2721, email: [email protected].. Patricio Garcia, Center for Devices and Clinical Chemistry and Radiological Health, Food and Drug Clinical Toxicology Administration, 10903 New Hampshire Ave., Devices Panel. Bldg. 66, Rm. G610, Silver Spring, MD 20993- 0002, phone: 301-796-6875, email: [email protected].. Evella Washington, Center for Devices and Ear, Nose and Throat Radiological Health, Food and Drug Devices Panel, Administration, 10903 New Hampshire Ave., Immunology Devices Bldg. 66, Rm. 1535, Silver Spring, MD 20993- Panel. 0002, phone: 301-796-6683, email: [email protected].. Pamela Scott, Center for Devices and Medical Devices Dispute Radiological Health, Food and Drug Resolution. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993- 0002, phone: 301-796-5433, email: [email protected].. Aden Asefa, Center for Devices and Neurological Devices Radiological Health, Food and Drug Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2648, Silver Spring, MD 20993- 0002, phone: 301-796-0400, email: [email protected].. LaToya Bonner, Center for Drug Evaluation and Endocrinologic and Research, Food and Drug Administration, Metabolic Drugs Advisory 10903 New Hampshire Ave., Bldg. 31, Rm. Committee. 2428, Silver Spring, MD 20993-0002, phone: 301-796-2855, email: [email protected].. Karen Strambler, Center for Food Safety and Foods Advisory Committee. Nutrition, Food and Drug Administration, FDA College Park, CPK1, Rm. 1C008, College Park, MD 20740, phone: 240-402-2589, email: [email protected].. Cindy Hong, Center for Drug Evaluation and Gastrointestinal Drugs Research, Food and Drug Administration, Advisory Committee, 10903 New Hampshire Ave., Bldg. 31, Rm. Pulmonary-Allergy Drugs 2430, Silver Spring, MD 20993-0002, phone: Advisory Committee. 301-796-0889, email: [email protected].. Jennifer Shepherd, Center for Drug Evaluation Medical Imaging Advisory and Research, Food and Drug Administration, Committee, 10903 New Hampshire Ave., Bldg. 31, Rm. Pharmaceutical Science 2434, Silver Spring, MD 20993-0002, phone: and Clinical 301-796-4043, email: Pharmacology. [email protected].. Sara Anderson, Center for Devices and National Mammography Radiological Health, Food and Drug Quality Assurance Administration, 10903 New Hampshire Ave., Advisory Committee. Bldg. 66, Rm. 1643, Silver Spring, MD 20993- 0002, phone: 301-796-0889, email: [email protected].. Moon Hee Choi, Center for Drug Evaluation and Non-Prescription Drugs Research, Food and Drug Administration, Advisory Committee, 10903 New Hampshire Ave., Bldg. 31, Rm. Peripheral & Central 2434, Silver Spring, MD 20993-0002, phone: Nervous Systems Advisory 301-796-2894, email: Committee. [email protected].. Marie ann Brill, Office of the Commissioner, Pediatrics Advisory Office of Medical Products and Tobacco, Food Committee. and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993-0002, phone: 240-402-3838, email: [email protected].. ------------------------------------------------------------------------ SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2. Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed ---------------------------------------------------------------------------------------------------------------- Committee/panel/areas of expertise needed Type of vacancy Approximate date needed ---------------------------------------------------------------------------------------------------------------- Antimicrobial Advisory Committee-- 1--Voting....................... November 30, 2017. Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Clinical Chemistry and Clinical 1--Non-Voting................... February 28, 2017. Toxicology Devices Panel--Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology. Ear, Nose and Throat Devices Panel-- 1--Non-Voting................... Immediately. Otologists, neurologists, audiologists. Immunology Devices--Persons with 1--Non-Voting................... Immediately. experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine. Medical Devices Dispute Resolution-- 1--Non-Voting................... Immediately. Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills. Neurological Devices Panel--Neurosurgeons 1--Non-Voting................... Immediately. (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians. Endocrinologic and Metabolic Drugs 1--Voting....................... June 30, 2017. Advisory Committee--Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties. Foods Advisory Committee--Knowledgeable 1--Voting....................... June 30, 2017. in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines. Gastrointestinal Drugs Advisory 1--Voting....................... Immediately. Committee--Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Pulmonary-Allergy Drugs Advisory 1--Voting....................... May 31, 2017. Committee--Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics. [[Page 27499]] Medical Imaging Advisory Committee-- 1--Voting....................... Immediately. Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties. Pharmaceutical Science and Clinical 1--Voting....................... Immediately. Pharmacology--Knowledgeable in the fields of pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability and bioequivalence research, the design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics, and related biomedical and pharmacological specialties. National Mammography Quality Assurance 1--Non-Voting................... Immediately. Advisory Committee--Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Non-Prescription Drugs Advisory 1--Voting....................... May 31, 2017. Committee--Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Peripheral and Central Nervous System 1--Voting....................... Immediately. Drugs Advisory Committee--Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties. Pediatrics Advisory Committee-- 1--Voting....................... Immediately. Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and one representative from a relevant patient or patient-family organization and may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. ---------------------------------------------------------------------------------------------------------------- I. Functions and General Description of the Committee Duties A. Antimicrobial Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders. B. Certain Panels of the Medical Devices Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area: (1) Advises on the classification or reclassification of devices into one of three regulatory categories; (2) advises on any possible risks to health associated with the use of devices; (3) advises on formulation of product development protocols; (4) reviews premarket approval applications for medical devices; (5) reviews guidelines and guidance documents; (6) recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; (7) advises on the necessity to ban a device; and (8) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions. C. Endocrinologic and Metabolic Drugs Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders. D. Food Advisory Committee Make recommendations on emerging food safety, food science, nutrition, and other food-related health issues that FDA considers of primary importance for its food and cosmetics programs. Reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food or cosmetic related issues; (2) the safety of new foods and food ingredients; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. E. Gastrointestinal Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases. F. Pulmonary-Allergy Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms. G. Medical Imaging Drugs Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology. H. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Provide advice on scientific and technical issues concerning the safety, [[Page 27500]] and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases, and as required, any other product for which FDA has regulatory responsibility. The committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA's generic drug regulatory responsibilities. I. National Mammography Quality Assurance Advisory Committee Advise the Agency on the following development of appropriate quality standards and regulations for mammography facilities; standards and regulations for bodies accrediting mammography facilities under this program; regulations with respect to sanctions; procedures for monitoring compliance with standards; establishing a mechanism to investigate consumer complaints; reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities. As well as determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and determining the costs and benefits of compliance with these requirements. J. Non-Prescription Drugs Advisory Committee Review and evaluate available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advise the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee will serve as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency sponsored intramural and extramural scientific biomedical programs in support of FDA's mission and regulatory responsibilities. K. Peripheral and Central Nervous System Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases. L. Pediatrics Advisory Committee The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding: (1) Pediatric research; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions, (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics, (4) pediatric labeling disputes, (5) pediatric labeling changes, (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur, (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products, (8) research involving children as subjects, and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services. II. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate an affiliation with and/or active participation in consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel. IV. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations should include a cover letter and current curriculum vitae or r[eacute]sum[eacute] for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations should also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process [[Page 27501]] with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: June 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation and Analysis. [FR Doc. 2017-12352 Filed 6-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27497
begins. The approval phase starts with biologics license application (BLA) for in participating in the selection of
the initial submission of an application NATPARA (BLA 125511) was initially voting and/or nonvoting consumer
to market the human biological product submitted on October 24, 2013. representatives to serve on its advisory
and continues until FDA grants 3. The date the application was committees or panels notify FDA in
permission to market the biological approved: January 23, 2015. FDA has writing. FDA is also requesting
product. Although only a portion of a verified the applicant’s claim that BLA nominations for voting and/or
regulatory review period may count 125511 was approved on January 23, nonvoting consumer representatives to
toward the actual amount of extension 2015. serve on advisory committees and/or
that the Director of USPTO may award This determination of the regulatory panels for which vacancies currently
(for example, half the testing phase must review period establishes the maximum exist or are expected to occur in the near
be subtracted as well as any time that potential length of a patent extension. future. Nominees recommended to serve
may have occurred before the patent However, the USPTO applies several as a voting or nonvoting consumer
was issued), FDA’s determination of the statutory limitations in its calculations representative may be self-nominated or
length of a regulatory review period for of the actual period for patent extension. may be nominated by a consumer
a human biological product will include In its application for patent extension, organization.
all of the testing phase and approval this applicant seeks 5 years of patent FDA seeks to include the views of
phase as specified in 35 U.S.C. term extension. women and men, members of all racial
156(g)(1)(B). and ethnic groups, and individuals with
FDA has approved for marketing the III. Petitions and without disabilities on its advisory
human biologic product NATPARA Anyone with knowledge that any of committees and, therefore, encourages
(parathyroid hormone (recombinant the dates as published are incorrect may nominations of appropriately qualified
human)). NATPARA is indicated as an submit either electronic or written candidates from these groups.
adjunct to calcium and vitamin D to comments and ask for a redetermination DATES: Any consumer organization
control hypocalcemia in patients with (see DATES). Furthermore, any interested interested in participating in the
hypoparathyroidism. Subsequent to this person may petition FDA for a selection of an appropriate voting or
approval, the USPTO received a patent determination regarding whether the nonvoting member to represent
term restoration application for applicant for extension acted with due consumer interests on an FDA advisory
NATPARA (U.S. Patent No. 5,496,801) diligence during the regulatory review committee or panel may send a letter or
from NPS Pharmaceuticals Inc., and the period. To meet its burden, the petition email stating that interest to FDA (see
USPTO requested FDA’s assistance in must be timely (see ADDRESSES) and ADDRESSES) by July 17, 2017, for
determining this patent’s eligibility for contain sufficient facts to merit an FDA vacancies listed in this notice.
patent term restoration. In a letter dated investigation. (See H. Rept. 857, part 1, Concurrently, nomination materials for
March 10, 2016, FDA advised the 98th Cong., 2d sess., pp. 41–42, 1984.) prospective candidates should be sent to
USPTO that this human biological Petitions should be in the format FDA (see ADDRESSES) by July 17, 2017.
product had undergone a regulatory specified in 21 CFR 10.30. Nominations will be accepted for
review period and that the approval of Submit petitions electronically to current vacancies and for those that will
NATPARA represented the first https://www.regulations.gov at Docket or may occur through November 30,
permitted commercial marketing or use No. FDA–2013–S–0610. Submit written 2017.
of the product. Thereafter, the USPTO petitions (two copies are required) to the
ADDRESSES: All statements of interest
requested that FDA determine the Division of Dockets Management (HFA–
product’s regulatory review period. 305), Food and Drug Administration, from consumer organizations interested
5630 Fishers Lane, Rm. 1061, Rockville, in participating in the selection process
II. Determination of Regulatory Review and consumer representative
MD 20852.
Period nominations should be submitted
Dated: June 9, 2017. electronically to ACOMSSubmissions@
FDA has determined that the
Anna K. Abram, fda.hhs.gov, by mail to Advisory
applicable regulatory review period for
NATPARA is 7,268 days. Of this time, Deputy Commissioner for Policy, Planning, Committee Oversight and Management
Legislation, and Analysis. Staff, 10903 New Hampshire Ave., Bldg.
6,811 days occurred during the testing
[FR Doc. 2017–12359 Filed 6–14–17; 8:45 am] 32, Rm. 5103, Silver Spring, MD 20993–
phase of the regulatory review period,
while 457 days occurred during the BILLING CODE 4164–01–P 0002, or by FAX: 301–847–8640.
approval phase. These periods of time Consumer representative nominations
were derived from the following dates: should be submitted electronically by
1. The date an exemption under DEPARTMENT OF HEALTH AND logging into the FDA Advisory
section 505(i) of the Federal Food, Drug, HUMAN SERVICES Committee Membership Nomination
and Cosmetic Act (21 U.S.C. 355(i)) Portal at: https://
Food and Drug Administration www.accessdata.fda.gov/scripts/
became effective: March 3, 1995. The
applicant claims January 31, 1995, as [Docket No. FDA–2017–N–0001] FACTRSPortal/FACTRS/index.cfm, by
the date the investigational new drug mail to Advisory Committee Oversight
application (IND) became effective. Request for Nominations for and Management Staff, 10903 New
However, FDA records indicate that the Individuals and Consumer Hampshire Ave., Bldg. 32, Rm. 5103,
IND effective date was March 3, 1995, Organizations for Advisory Silver Spring, MD 20993–0002, or by
Committees
pmangrum on DSK3GDR082PROD with NOTICES
which was 30 days after FDA receipt of FAX: 301–847–8640. Additional
the IND. AGENCY: Food and Drug Administration, information about becoming a member
2. The date the application was HHS. on an FDA advisory committee can also
initially submitted with respect to the be obtained by visiting FDA’s Web site
ACTION: Notice.
human biological product under section at http://www.fda.gov/
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug AdvisoryCommittees/default.htm.
U.S.C. 262): October 24, 2013. FDA has Administration (FDA) is requesting that FOR FURTHER INFORMATION CONTACT: For
verified the applicant’s claim that the any consumer organizations interested questions relating to participation in the
VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1](https://thefederalregister.org/doc/82_FR_27611/page/1.svg)
![Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27501
with the opportunity to vote on the • Federal eRulemaking Portal: copies total. One copy will include the
listed nominees. Only organizations https://www.regulations.gov. Follow the information you claim to be confidential
vote in the selection process. Persons instructions for submitting comments. with a heading or cover note that states
who nominate themselves to serve as Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS
voting or nonvoting consumer including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The
representatives will not participate in www.regulations.gov will be posted to Agency will review this copy, including
the selection process. the docket unchanged. Because your the claimed confidential information, in
This notice is issued under the comment will be made public, you are its consideration of comments. The
Federal Advisory Committee Act (5 solely responsible for ensuring that your second copy, which will have the
U.S.C. app. 2) and 21 CFR part 14, comment does not include any claimed confidential information
relating to advisory committees. confidential information that you or a redacted/blacked out, will be available
Dated: June 9, 2017. third party may not wish to be posted, for public viewing and posted on
such as medical information, your or https://www.regulations.gov. Submit
Anna K. Abram,
anyone else’s Social Security number, or both copies to the Division of Dockets
Deputy Commissioner for Policy, Planning, confidential business information, such
Legislation and Analysis. Management. If you do not wish your
as a manufacturing process. Please note name and contact information to be
[FR Doc. 2017–12352 Filed 6–14–17; 8:45 am]
that if you include your name, contact made publicly available, you can
BILLING CODE 4164–01–P information, or other information that provide this information on the cover
identifies you in the body of your sheet and not in the body of your
comments, that information will be comments and you must identify this
DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov.
HUMAN SERVICES information as ‘‘confidential.’’ Any
• If you want to submit a comment information marked as ‘‘confidential’’
with confidential information that you will not be disclosed except in
Food and Drug Administration
do not wish to be made available to the accordance with 21 CFR 10.20 and other
[Docket No. FDA–2009–N–0505] public, submit the comment as a applicable disclosure law. For more
written/paper submission and in the information about FDA’s posting of
Agency Information Collection manner detailed (see ‘‘Written/Paper comments to public dockets, see 80 FR
Activities; Proposed Collection; Submissions’’ and ‘‘Instructions’’). 56469, September 18, 2015, or access
Comment Request; Recordkeeping
Written/Paper Submissions the information at: http://www.gpo.gov/
and Reporting Requirements for
fdsys/pkg/FR-2015-09-18/pdf/2015-
Human Food and Cosmetics Submit written/paper submissions as
23389.pdf.
Manufactured From, Processed With, follows: Docket: For access to the docket to
or Otherwise Containing Material From • Mail/Hand delivery/Courier (for
read background documents or the
Cattle written/paper submissions): Division of
electronic and written/paper comments
Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration, received, go to https://
and Drug Administration, 5630 Fishers
HHS. www.regulations.gov and insert the
Lane, Rm. 1061, Rockville, MD 20852.
ACTION: Notice. • For written/paper comments docket number, found in brackets in the
submitted to the Division of Dockets heading of this document, into the
SUMMARY: The Food and Drug Management, FDA will post your ‘‘Search’’ box and follow the prompts
Administration (FDA) is announcing an comment, as well as any attachments, and/or go to the Division of Dockets
opportunity for public comment on the except for information submitted, Management, 5630 Fishers Lane, Rm.
proposed collection of certain marked and identified, as confidential, 1061, Rockville, MD 20852.
information by the Agency. Under the if submitted as detailed in FOR FURTHER INFORMATION CONTACT: Ila
Paperwork Reduction Act of 1995 (the ‘‘Instructions.’’ S. Mizrachi, Office of Operations, Food
PRA), Federal Agencies are required to Instructions: All submissions received and Drug Administration, Three White
publish notice in the Federal Register must include the Docket No. FDA– Flint North, 10A63, 11601 Landsdown
concerning each proposed collection of 2009–N–0505 for ‘‘Agency Information St., North Bethesda, MD 20852, 301–
information, including each proposed Collection Activities; Proposed 796–7726.
extension of an existing collection of Collection; Comment Request; SUPPLEMENTARY INFORMATION: Under the
information, and to allow 60 days for Recordkeeping and Reporting PRA (44 U.S.C. 3501–3520), Federal
public comment in response to the Requirements for Human Food and Agencies must obtain approval from the
notice. This notice solicits comments on Cosmetics Manufactured From, Office of Management and Budget
the information collection provisions of Processed With, or Otherwise (OMB) for each collection of
existing FDA regulations concerning Containing Material From Cattle.’’ information they conduct or sponsor.
FDA-regulated human food, including Received comments will be placed in ‘‘Collection of information’’ is defined
dietary supplements, and cosmetics the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
manufactured from, processed with, or submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
otherwise containing material derived Submissions,’’ publicly viewable at or requirements that members of the
from cattle. https://www.regulations.gov or at the public submit reports, keep records, or
DATES: Submit either electronic or Division of Dockets Management provide information to a third party.
pmangrum on DSK3GDR082PROD with NOTICES
written comments on the collection of between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
information by August 14, 2017. through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
ADDRESSES: You may submit comments • Confidential Submissions—To Agencies to provide a 60-day notice in
as follows: submit a comment with confidential the Federal Register concerning each
information that you do not wish to be proposed collection of information,
Electronic Submissions made publicly available, submit your including each proposed extension of an
Submit electronic comments in the comments only as a written/paper existing collection of information,
following way: submission. You should submit two before submitting the collection to OMB
VerDate Sep<11>2014 14:10 Jun 14, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1](https://thefederalregister.org/doc/82_FR_27611/page/5.svg)
Document Created: 2017-06-15 01:03:42
Document Modified: 2017-06-15 01:03:42
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a | |
| Contact | For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, 301- 796-8220, email: [email protected] | |
| FR Citation | 82 FR 27497 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR