83 FR 15578 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 70 (April 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 70 (April 11, 2018)
| Page Range | 15578-15581 | |
| FR Document | 2018-07426 |
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)] [Notices] [Pages 15578-15581] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07426] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1095] 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 or Agency) 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 May 11, 2018, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by May 11, 2018. Nominations will be accepted for current vacancies and for those that will or may occur through July 31, 2018. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to ACOMSSubmissions@fda.hhs.gov, by mail or delivery service 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: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm; by mail or delivery service 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 of an FDA advisory committee can also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION 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: kimberly.hamilton@fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate contact person listed in table 1. [[Page 15579]] Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Moon Hee V. Choi, Center for Drug Evaluation Anesthetic and Analgesic and Research, Food and Drug Administration, Drug Products Advisory 10903 New Hampshire Ave., Bldg. 31, Rm. Committee. 2434, Silver Spring, MD 20993-0002, 301-796- 2894, email: MoonHee.Choi@fda.hhs.gov. 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, 301-796- 2721, email: Lauren.Tesh@fda.hhs.gov. Kalyani Bhatt, Center for Drug Evaluation and Bone, Reproductive and Research, Food and Drug Administration, Urological Drugs 10903 New Hampshire Ave., Bldg. 31, Rm. Advisory Committee. 2438, Silver Spring, MD 20993-0002, 301-796- 9005, email: Kalyani.Bhatt@fda.hhs.gov. Jennifer Shepherd, Center for Drug Evaluation Cardiovascular and Renal and Research, Food and Drug Administration, Drugs Advisory 10903 New Hampshire Ave., Bldg. 31, Rm. Committee, Medical 2434, Silver Spring, MD 20993-0002, 301-796- Imaging Advisory 4043, email: Jennifer.Shepherd@fda.hhs.gov. Committee. Cindy Chee, Center for Drug Evaluation and Pulmonary-Allergy Drugs Research, Food and Drug Administration, Advisory Committee. 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993-0002, 301-796- 0889, email: Cindy.Chee@fda.hhs.gov. 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- Gastroenterology and 0002, 301-796-6875, email: Urology Devices Panel. Patricio.Garcia@fda.hhs.gov. Evella Washington, Center for Devices and Ear, Nose and Throat Radiological Health, Food and Drug Devices Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993- 0002, 301-796-6683, email: Evella.Washington@fda.hhs.gov. Joan Adams-White, Center for Devices and Medical Devices Dispute Radiological Health, Food and Drug Resolution Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm., 5572, Silver Spring, MD 20993- 0002, 301-796-5421, email: Joannie.Adams-White@fda.hhs.gov. Aden Asefa, Center for Devices and Microbiology Devices Radiological Health, Food and Drug Panel, Radiology Devices Administration, 10903 New Hampshire Ave., Panel. Bldg. 66, Rm. G642, Silver Spring, MD 20993- 0002, 301-796-0400, email: Aden.Asefa@fda.hhs.gov. Sara Anderson, Center for Devices and Orthopaedic and Radiological Health, Food and Drug Rehabilitation Devices Administration, 10903 New Hampshire Ave., Panel, Radiological Bldg. 66, Rm. G616 Silver Spring, MD 20993- Devices Panel. 0002, 301-796-7047, email: Sara.Anderson@fda.hhs.gov. ------------------------------------------------------------------------ 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 Approximate date expertise needed Type of vacancy needed ------------------------------------------------------------------------ Anesthetic and Analgesic Drug 1--Voting........ Immediately. Products Advisory Committee-- Knowledgeable in the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties. Antimicrobial Advisory 1--Voting........ Immediately. Committee--Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties. Bone, Reproductive and 1--Voting........ Immediately. Urological Drugs Advisory Committee--Knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties. Cardiovascular and Renal Drugs 1--Voting........ July 1, 2018. Advisory Committee-- Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics. Medical Imaging Advisory 1--Voting........ Immediately. Committee--Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics and related specialties. Pulmonary- Allergy Drugs 1--Voting........ Immediately. Advisory Committee-- Knowledgeable in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology or statistics. Clinical Chemistry and 1--Non-Voting.... Immediately. Clinical 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. Gastroenterology and Urology 1--Non-Voting.... Immediately. Devices Panel-- Gastroenterologists, urologists and nephrologists. Radiology Devices Panel-- 1--Non-Voting.... Immediately. Physicians with experience in general radiology, mammography, ultrasound, magnetic resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and image analysis. Ear, Nose and Throat Devices 1--Non-Voting.... Immediately. Panel--Experts in Otologists, neurologists, audiologists. [[Page 15580]] Medical Devices Dispute 1--Non-Voting.... Immediately. Resolution--Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills. Microbiology Devices Panel-- 1--Non-Voting.... Immediately. Clinicians with an expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists. Orthopaedic and Rehabilitation 1--Non-Voting.... Immediately. Devices Panel--Orthopedic surgeons (joint spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians. ------------------------------------------------------------------------ I. Functions and General Description of the Committee Duties A. Anesthetic and Analgesic Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in anesthesiology and surgery. B. 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. C. Bone, Reproductive & Urologic Drugs Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, and related specialties. D. Cardiovascular and Renal 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 cardiovascular and renal disorders. E. Medical Imaging 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. 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. Certain Panels of the Medical Devices Advisory Committee Review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a device; and 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. 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 [[Page 15581]] 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 resume. Ballots must 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 must include a current, complete r[eacute]sum[eacute] or curriculum vitae for each nominee and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES section of this document), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations must also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations must also acknowledge 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 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: April 5, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07426 Filed 4-10-18; 8:45 am] BILLING CODE 4164-01-P
![15578 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
Application No. Drug Applicant
ANDA 077173 ........ Ondansetron Injection USP, EQ 2 mg base/milliliter (mL) .... Sun Pharmaceutical Industries Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 078598 ........ Ciprofloxacin Ophthalmic Solution USP, EQ 0.3% base ....... Amring Pharmaceuticals, Inc., 1235 Westlakes Dr., Suite
205, Berwyn, PA 19312.
ANDA 078805 ........ Irinotecan HCl Injection, 20 mg/mL ........................................ Sun Pharma Global FZE, c/o Sun Pharmaceutical Indus-
tries, Inc., 2 Independence Way, Princeton, NJ 08540.
ANDA 086024 ........ Capital and Codeine (acetaminophen and codeine phos- Valeant Pharmaceuticals North America, LLC, 400 Som-
phate) Oral Suspension USP, 120 mg/12 mg per 5 mL. erset Corporate Blvd., Bridgewater, NJ 08807.
ANDA 091180 ........ Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, Zambon S.p.A., c/o Camargo Pharmaceutical Services,
EQ 2% base/EQ 0.5% base. LLC, 9825 Kenwood Rd., Suite 203, Cincinnati, OH
45242.
ANDA 203176 ........ Nevirapine Tablets USP, 200 mg .......................................... Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
ANDA 204900 ........ Amlodipine Besylate Tablets USP, EQ 2.5 mg base, EQ 5 Sovereign Pharmaceuticals, LLC, 7590 Sand St., Fort
mg base, and EQ 10 mg base. Worth, TX 76118.
ANDA 209480 ........ Clozapine Tablets USP, 25 mg, 50 mg, 100 mg, and 200 Zydus Pharmaceuticals USA, Inc., 73 Route 31 North, Pen-
mg. nington, NJ 08534.
Therefore, approval of the requesting that any consumer and consumer representative
applications listed in the table, and all organizations interested in participating nominations should be submitted
amendments and supplements thereto, in the selection of voting and/or electronically to ACOMSSubmissions@
is hereby withdrawn as of May 11, 2018. nonvoting consumer representatives to fda.hhs.gov, by mail or delivery service
Introduction or delivery for introduction serve on its advisory committees or to Advisory Committee Oversight and
into interstate commerce of products panels notify FDA in writing. FDA is Management Staff, 10903 New
without approved new drug also requesting nominations for voting Hampshire Ave., Bldg. 32, Rm. 5103,
applications violates section 301(a) and and/or nonvoting consumer Silver Spring, MD 20993–0002, or by
(d) of the Federal Food, Drug, and representatives to serve on advisory Fax: 301–847–8640.
Cosmetic Act (21 U.S.C. 331(a) and (d)). committees and/or panels for which Consumer representative nominations
Drug products that are listed in the table vacancies currently exist or are expected should be submitted electronically by
that are in inventory on May 11, 2018 to occur in the near future. Nominees logging into the FDA Advisory
may continue to be dispensed until the recommended to serve as a voting or Committee Membership Nomination
inventories have been depleted or the nonvoting consumer representative may Portal: https://www.accessdata.fda.gov/
drug products have reached their be self-nominated or may be nominated scripts/FACTRSPortal/FACTRS/
expiration dates or otherwise become by a consumer organization. index.cfm; by mail or delivery service to
violative, whichever occurs first. FDA seeks to include the views of
Advisory Committee Oversight and
women and men, members of all racial
Dated: April 5, 2018. Management Staff, 10903 New
and ethnic groups, and individuals with
Leslie Kux, Hampshire Ave., Bldg. 32, Rm. 5103,
and without disabilities on its advisory
Associate Commissioner for Policy. Silver Spring, MD 20993–0002; or by
committees, and therefore encourages
Fax: 301–847–8640. Additional
[FR Doc. 2018–07440 Filed 4–10–18; 8:45 am] nominations of appropriately qualified
information about becoming a member
BILLING CODE 4164–01–P candidates from these groups.
of an FDA advisory committee can also
DATES: Any consumer organization
be obtained by visiting FDA’s website at
interested in participating in the https://www.fda.gov/
DEPARTMENT OF HEALTH AND selection of an appropriate voting or
HUMAN SERVICES AdvisoryCommittees/default.htm.
nonvoting member to represent
consumer interests on an FDA advisory FOR FURTHER INFORMATION CONTACT: For
Food and Drug Administration questions relating to participation in the
committee or panel may send a letter or
[Docket No. FDA–2018–N–1095] email stating that interest to FDA (see selection process: Kimberly Hamilton,
ADDRESSES) by May 11, 2018, for Advisory Committee Oversight and
Request for Nominations for vacancies listed in this notice. Management Staff (ACOMS), Food and
Individuals and Consumer Concurrently, nomination materials for Drug Administration, 10903 New
Organizations for Advisory prospective candidates should be sent to Hampshire Ave., Bldg. 32, Rm. 5103,
Committees FDA (see ADDRESSES) by May 11, 2018. Silver Spring, MD 20993–0002, 301–
AGENCY: Food and Drug Administration, Nominations will be accepted for 796–8220, email: kimberly.hamilton@
HHS. current vacancies and for those that will fda.hhs.gov.
ACTION: Notice. or may occur through July 31, 2018. For questions relating to specific
ADDRESSES: All statements of interest advisory committees or panels, contact
SUMMARY: The Food and Drug from consumer organizations interested the appropriate contact person listed in
Administration (FDA or Agency) is in participating in the selection process table 1.
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![Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15581
health branches of Federal, State, and participating in the selection process the likelihood that substantial
local governments also may participate with the opportunity to vote on the differences will exist among regions for
in the selection process. Any consumer listed nominees. Only organizations the acceptance of data generated in
organization interested in participating vote in the selection process. Persons pediatric global drug development
in the selection of an appropriate voting who nominate themselves to serve as programs and ensure timely access to
or nonvoting member to represent voting or nonvoting consumer medicines for children.
consumer interests should send a letter representatives will not participate in DATES: The announcement of the
stating that interest to FDA (see the selection process. guidance is published in the Federal
ADDRESSES) within 30 days of This notice is issued under the Register on April 11, 2018.
publication of this document. Federal Advisory Committee Act (5 ADDRESSES: You may submit either
Within the subsequent 30 days, FDA U.S.C. app. 2) and 21 CFR part 14,
will compile a list of consumer electronic or written comments on
relating to advisory committees. Agency guidances at any time as
organizations that will participate in the
Dated: April 5, 2018. follows:
selection process and will forward to
each such organization a ballot listing at Leslie Kux,
Electronic Submissions
least two qualified nominees selected by Associate Commissioner for Policy.
[FR Doc. 2018–07426 Filed 4–10–18; 8:45 am] Submit electronic comments in the
the Agency based on the nominations
following way:
received, together with each nominee’s BILLING CODE 4164–01–P
current curriculum vitae or resume. • Federal eRulemaking Portal:
Ballots must be filled out and returned https://www.regulations.gov. Follow the
to FDA within 30 days. The nominee DEPARTMENT OF HEALTH AND instructions for submitting comments.
receiving the highest number of votes HUMAN SERVICES Comments submitted electronically,
ordinarily will be selected to serve as including attachments, to https://
the member representing consumer Food and Drug Administration www.regulations.gov will be posted to
interests for that particular advisory the docket unchanged. Because your
[Docket No. FDA–2016–D–3848]
committee or panel. comment will be made public, you are
E11(R1) Addendum: Clinical solely responsible for ensuring that your
IV. Nomination Procedures comment does not include any
Investigation of Medicinal Products in
Any interested person or organization the Pediatric Population; International confidential information that you or a
may nominate one or more qualified Council for Harmonisation; Guidance third party may not wish to be posted,
persons to represent consumer interests for Industry; Availability such as medical information, your or
on the Agency’s advisory committees or anyone else’s Social Security number, or
panels. Self-nominations are also AGENCY: Food and Drug Administration, confidential business information, such
accepted. Nominations must include a HHS. as a manufacturing process. Please note
current, complete résumé or curriculum ACTION: Notice of availability. that if you include your name, contact
vitae for each nominee and a signed information, or other information that
copy of the Acknowledgement and SUMMARY: The Food and Drug identifies you in the body of your
Consent form available at the FDA Administration (FDA or Agency) is comments, that information will be
Advisory Nomination Portal (see announcing the availability of a posted on https://www.regulations.gov.
ADDRESSES section of this document), guidance for industry entitled ‘‘E11(R1) • If you want to submit a comment
and a list of consumer or community- Addendum: Clinical Investigation of with confidential information that you
based organizations for which the Medicinal Products in the Pediatric do not wish to be made available to the
candidate can demonstrate active Population’’ (E11(R1) addendum or public, submit the comment as a
participation. addendum). The guidance was prepared written/paper submission and in the
Nominations must also specify the under the auspices of the International manner detailed (see ‘‘Written/Paper
advisory committee(s) or panel(s) for Council for Harmonisation (ICH), Submissions’’ and ‘‘Instructions’’).
which the nominee is recommended. In formerly the International Conference
on Harmonisation. The guidance is an Written/Paper Submissions
addition, nominations must also
acknowledge that the nominee is aware addendum to the guidance published in Submit written/paper submissions as
of the nomination unless self- 2000 entitled ‘‘E11 Clinical follows:
nominated. FDA will ask potential Investigation of Medicinal Products in • Mail/Hand delivery/Courier (for
candidates to provide detailed the Pediatric Population’’ (ICH E11 written/paper submissions): Dockets
information concerning such matters as (2000)), and provides updates to the Management Staff (HFA–305), Food and
financial holdings, employment, and original guidance. This addendum does Drug Administration, 5630 Fishers
research grants and/or contracts to not alter the scope of the original Lane, Rm. 1061, Rockville, MD 20852.
permit evaluation of possible sources of guidance, which outlines an approach • For written/paper comments
conflicts of interest. Members will be to the safe, efficient, and ethical study submitted to the Dockets Management
invited to serve for terms up to 4 years. of medicinal products in the pediatric Staff, FDA will post your comment, as
FDA will review all nominations population. This addendum well as any attachments, except for
received within the specified complements and provides clarification information submitted, marked and
timeframes and prepare a ballot and current regulatory perspective on identified, as confidential, if submitted
containing the names of qualified topics in pediatric drug development. as detailed in ‘‘Instructions.’’
amozie on DSK30RV082PROD with NOTICES
nominees. Names not selected will The guidance is intended to provide Instructions: All submissions received
remain on a list of eligible nominees high-level guidance on the must include the Docket No. FDA–
and be reviewed periodically by FDA to implementation of important 2016–D–3848 for ‘‘E11(R1) Addendum:
determine continued interest. Upon approaches in pediatric drug Clinical Investigation of Medicinal
selecting qualified nominees for the development. This harmonized Products in the Pediatric Population.’’
ballot, FDA will provide those addendum will help to define the Received comments will be placed in
consumer organizations that are current recommendations and reduce the docket and, except for those
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Document Created: 2018-04-10 23:59:12
Document Modified: 2018-04-10 23:59:12
| 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 | 83 FR 15578 |
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