82 FR 28661 - Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 120 (June 23, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 120 (June 23, 2017)
| Page Range | 28661-28664 | |
| FR Document | 2017-13182 |
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)] [Notices] [Pages 28661-28664] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13182] [[Page 28661]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. In accordance with the 21st Century Cures Act, this notice provides an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. 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: Nominations received on or before August 22, 2017, will be given first consideration for membership on the Device Good Manufacturing Practice Advisory Committee and Panels of the Medical Devices Advisory Committee. Nominations received after August 22, 2017, will be considered for nomination to the committee as later vacancies occur. ADDRESSES: All nominations for membership should be submitted electronically by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, contact the following persons listed in table 1: Table 1--Committee Contact ------------------------------------------------------------------------ Primary contact person or designated federal officer Committee ------------------------------------------------------------------------ Sara Anderson, Office of Device Dental Products Panel, Evaluation, Center for Devices and Hematology and Pathology Radiological Health, Food and Drug Devices Panel, Orthopaedic and Administration, 10903 New Hampshire Rehabilitation Devices Panel. Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301-796-7047, email: [email protected]. Aden S. Asefa, Office of Device General Hospital and Personal Evaluation, Center for Devices and Use Devices Panel, Radiological Health, Food and Drug Neurological Devices Panel, Administration, 10903 New Hampshire Ophthalmic Devices Panel, Ave., Bldg. 66, Rm. G642, Silver Immunology Devices Panel, Spring, MD 20993, 301-796-0400, email: Device Good Manufacturing [email protected]. Practice Advisory Committee. Shanika Craig, Office of Device Anesthesiology and Respiratory Evaluation, Center for Devices and Therapy Devices Panel, Radiological Health, Food and Drug Microbiology Devices Panel, Administration, 10903 New Hampshire Obstetrics and Gynecology Ave., Bldg. 66, Rm. G644, Silver Devices Panel, Radiological Spring, MD 20993, 301-796-6639, email: Devices Panel. [email protected]. Patricio G. Garcia, Office of Device Clinical Chemistry and Clinical Evaluation, Center for Devices and Toxicology Panel, Radiological Health, Food and Drug Gastroenterology and Urology Administration, 10903 New Hampshire Devices Panel, General and Ave., Bldg. 66, Rm. G610, Silver Plastic Surgery Devices Panel. Spring, MD 20993, 301-796-6875, email: [email protected]. Pamela Scott, Office of the Center Medical Devices Dispute Director, Center for Devices and Resolution Panel. Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-5433, email: [email protected]. Evella F. Washington, Office of Device Circulatory System Devices Evaluation, Center for Devices and Panel, Ear, Nose and Throat Radiological Health, Food and Drug Devices Panel, Molecular and Administration, 10903 New Hampshire Clinical Genetics Devices Ave., Bldg. 66, Rm. G640, Silver Panel. Spring, MD 20993, 301-796-6683, email: [email protected]. ------------------------------------------------------------------------ SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting members for vacancies listed in table 2: Table 2--Expertise Needed, Vacancies, and Approximate Date Needed ------------------------------------------------------------------------ Upcoming Approximate date Committee expertise needed vacancies needed ------------------------------------------------------------------------ Device Good Manufacturing Practice 5 Immediately: Health Advisory Committee--Experts Professional (2). needed to provide cross-cutting June 1, 2017: scientific or clinical expertise Government concerning the particular issue Representatives (2) in dispute. Vacancies include a and General Public public representative and a Representative (1). government representative. Anesthesiology and Respiratory 3 December 1, 2017. Therapy Devices Panel of the Medical Devices Advisory Committee--Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia. [[Page 28662]] Circulatory System Devices Panel 1 July 1, 2017. of the Medical Devices Advisory Committee--Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure. Clinical Chemistry and Clinical 2 Immediately. Toxicology Panel of the Medical Devices Advisory Committee-- Doctors of medicine or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology. Dental Products Panel of the 3 November 1, 2017. Medical Devices Advisory Committee--Dentists, engineers, and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy. Ear, Nose and Throat Devices Panel 1 Immediately. of the Medical Devices Advisory 3 November 1, 2017. Committee--Otologists, neurotologists, and audiologists. Gastroenterology and Urology, 1 Immediately. Devices Panel of the Medical 2 January 1, 2018. Devices Advisory Committee-- Gastroenterologists, urologists, and nephrologists. General and Plastic Surgery 1 Immediately. Devices Panel of the Medical 2 September 1, 2017. Devices Advisory Committee-- Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians. General Hospital and Personal Use 1 Immediately. Devices Panel of the Medical 2 January 1, 2018. Devices Advisory Committee-- Internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, biomedical engineers or microbiologists/infection control practitioners or experts. Hematology and Pathology Devices 1 Immediately. Panel of the Medical Devices Advisory Committee--Hematologists (benign and/or malignant hematology), hematopathologists (general and special hematology, coagulation and homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers. Immunology Devices Panel of the 3 Immediately. Medical Devices Advisory Committee--Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine. Medical Devices Dispute Resolution 1 Immediately. Panel of the Medical Devices 1 October 1, 2017. Advisory Committee--Experts with cross-cutting scientific, clinical, analytical or mediation skills. Microbiology Devices Panel of the 5 Immediately. Medical Devices Advisory Committee--Infectious disease clinicians (e.g. pulmonary disease specialists, sexually transmitted disease specialists, pediatric ID specialists, tropical diseases specialists) and clinical microbiologists experienced in emerging infectious diseases; clinical microbiology laboratory directors; molecular biologists with experience in in vitro diagnostic device testing; virologists; hepatologists; or clinical oncologists experienced with tumor resistance and susceptibility. Molecular and Clinical Genetics 2 June 1, 2017. Devices Panel of the Medical Devices Advisory Committee-- Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, and clinical molecular genetics testing (e.g., genotyping, array CGH, etc.). Individuals with experience in genetics counseling, medical ethics are also desired, and individuals with experience in ancillary fields of study will be considered. Neurological Devices Panel of the 4 Immediately. Medical Devices Advisory 1 December 1, 2017. Committee--Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians. Obstetrics and Gynecology Devices 1 Immediately. Panel of the Medical Devices 3 February 1, 2018. Advisory Committee--Experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers with experience in obstetrics/ gynecology devices; urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing. Ophthalmic Devices Panel of the 1 Immediately. Medical Devices Advisory 2 November 1, 2017. Committee--Ophthalmologists specializing in cataract and refractive surgery and vitreo- retinal surgery, in addition to vision scientists, optometrists, and biostatisticians practiced in ophthalmic clinical trials. [[Page 28663]] Orthopaedic and Rehabilitation 2 September 1, 2017. Devices Panel of the Medical Devices Advisory Committee-- Orthopaedic surgeons (joint, spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians. Radiological Devices Panel of the 1 Immediately. Medical Devices Advisory-- 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. ------------------------------------------------------------------------ I. General Description of the Committees Duties A. Device Good Manufacturing Practice Advisory Committee The Committee reviews regulations proposed for issuance regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs (the Commissioner) regarding the feasibility and reasonableness of those proposed regulations. The committee also advises the Commissioner with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations that is referred to the committee. B. Medical Devices Advisory Committee The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act (the FD&C Act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area performs the following duties: (1) Advises the Commissioner regarding recommended 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 FD&C 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 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 Voting Members A. Device Good Manufacturing Practice Advisory Committee The Committee consists of a core of nine members including the Chair. Members and the Chair are selected by the Secretary of Health and Human Services. Persons nominated for membership as a health professional or officer or employee of any Federal, State, or local government should have knowledge of or expertise in any one or more of the following areas: Quality assurance concerning the design, manufacture, and use of medical devices. To be eligible for selection as a representative of the general public, nominees should possess appropriate qualifications to understand and contribute to the committee's work. Three of the members shall be officers or employees of any State or local government or of the Federal Government; two shall be representative of the interests of the device manufacturing industry; two shall be representatives of the interests of physicians and other health professionals; and two shall be representatives of the interests of the general public. Almost all non-Federal members of this committee serves as Special Government Employees. Members are invited to serve for overlapping terms of 4 years. The particular needs at this time for this committee are listed in Table 2 of this document. B. Panels of the Medical Devices Advisory Committee The Medical Devices Advisory Committee with its 18 panels shall consist of a maximum of 159 standing members. Members are selected by the Commissioner or designee from among authorities in clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. Almost all non-Federal members of this committee serve as Special Government Employees. A maximum of 122 members shall be standing voting members and 37 shall be nonvoting members who serve as representatives of consumer interests and of industry interests. FDA is publishing separate documents announcing the Request for Nominations Notification for Non-Voting Representatives on certain panels of the Medical Devices Advisory Committee. Persons nominated for membership on the panels should have adequately diversified experience appropriate to the work of the panel in such fields as clinical and [[Page 28664]] administrative medicine, engineering, biological and physical sciences, statistics, and other related professions. The nature of specialized training and experience necessary to qualify the nominee as an expert suitable for appointment may include experience in medical practice, teaching, and/or research relevant to the field of activity of the panel. The particular needs at this time for each panel are listed in table 2 of this document. Members will be invited to serve for terms of up to 4 years. III. Nomination Procedures Any interested person may nominate one or more qualified individuals for membership on one or more of the advisory panels or advisory committees. Self-nominations are also accepted. Nominations must include a current, complete resume or curriculum vitae for each nominee, including current business address and/or home address, telephone number, and email address if available. Nominations must also specify the advisory committee(s) for which the nominee is recommended. 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 related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. 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 20, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13182 Filed 6-22-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices 28661
DEPARTMENT OF HEALTH AND the Center for Devices and Radiological 2017, will be considered for nomination
HUMAN SERVICES Health. In accordance with the 21st to the committee as later vacancies
Century Cures Act, this notice provides occur.
Food and Drug Administration an annual opportunity for patients,
ADDRESSES: All nominations for
representatives of patients, and sponsors
[Docket No. FDA–2017–N–0001] membership should be submitted
of medical device submissions to
electronically by logging into the FDA
Request for Nominations for Voting provide recommendations for
Advisory Nomination Portal: https://
Members on Public Advisory Panels or individuals with appropriate expertise
www.accessdata.fda.gov/scripts/
Committees; Device Good to fill voting member positions on
FACTRSPortal/FACTRS/index.cfm or by
Manufacturing Practice Advisory classification panels.
FDA seeks to include the views of mail to Advisory Committee Oversight
Committee and the Medical Devices and Management Staff, Food and Drug
women and men, members of all racial
Advisory Committee Administration, 10903 New Hampshire
and ethnic groups, and individuals with
and without disabilities on its advisory Ave., Bldg. 32, Rm. 5103, Silver Spring,
AGENCY: Food and Drug Administration,
committees and, therefore, encourages MD 20993–0002. Information about
HHS.
nominations of appropriately qualified becoming a member on an FDA advisory
ACTION: Notice. committee can also be obtained by
candidates from these groups.
SUMMARY: The Food and Drug visiting FDA’s Web site at https://
DATES: Nominations received on or
Administration (FDA or Agency) is www.fda.gov/AdvisoryCommittees/
before August 22, 2017, will be given
requesting nominations for voting default.htm.
first consideration for membership on
members to serve on the Device Good the Device Good Manufacturing Practice FOR FURTHER INFORMATION CONTACT:
Manufacturing Practice Advisory Advisory Committee and Panels of the Regarding all nomination questions for
Committee and device panels of the Medical Devices Advisory Committee. membership, contact the following
Medical Devices Advisory Committee in Nominations received after August 22, persons listed in table 1:
TABLE 1—COMMITTEE CONTACT
Primary contact person or designated federal officer Committee
Sara Anderson, Office of Device Evaluation, Center for Devices and Dental Products Panel, Hematology and Pathology Devices Panel,
Radiological Health, Food and Drug Administration, 10903 New Orthopaedic and Rehabilitation Devices Panel.
Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993,
301–796–7047, email: Sara.Anderson@fda.hhs.gov.
Aden S. Asefa, Office of Device Evaluation, Center for Devices and General Hospital and Personal Use Devices Panel, Neurological De-
Radiological Health, Food and Drug Administration, 10903 New vices Panel, Ophthalmic Devices Panel, Immunology Devices Panel,
Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993, Device Good Manufacturing Practice Advisory Committee.
301–796–0400, email: Aden.Asefa@fda.hhs.gov.
Shanika Craig, Office of Device Evaluation, Center for Devices and Ra- Anesthesiology and Respiratory Therapy Devices Panel, Microbiology
diological Health, Food and Drug Administration, 10903 New Hamp- Devices Panel, Obstetrics and Gynecology Devices Panel, Radio-
shire Ave., Bldg. 66, Rm. G644, Silver Spring, MD 20993, 301–796– logical Devices Panel.
6639, email: Shanika.Craig@fda.hhs.gov.
Patricio G. Garcia, Office of Device Evaluation, Center for Devices and Clinical Chemistry and Clinical Toxicology Panel, Gastroenterology and
Radiological Health, Food and Drug Administration, 10903 New Urology Devices Panel, General and Plastic Surgery Devices Panel.
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
301–796–6875, email: Patricio.Garcia@fda.hhs.gov.
Pamela Scott, Office of the Center Director, Center for Devices and Medical Devices Dispute Resolution Panel.
Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301–
796–5433, email: Pamelad.Scott@fda.hhs.gov.
Evella F. Washington, Office of Device Evaluation, Center for Devices Circulatory System Devices Panel, Ear, Nose and Throat Devices
and Radiological Health, Food and Drug Administration, 10903 New Panel, Molecular and Clinical Genetics Devices Panel.
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993,
301–796–6683, email: Evella.Washington@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members for vacancies listed in table 2:
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED
Upcoming
Committee expertise needed Approximate date needed
vacancies
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Device Good Manufacturing Practice Advisory Committee—Experts needed to pro- 5 Immediately: Health Professional (2).
vide cross-cutting scientific or clinical expertise concerning the particular issue in June 1, 2017: Government Representa-
dispute. Vacancies include a public representative and a government representa- tives (2) and General Public Rep-
tive. resentative (1).
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Ad- 3 December 1, 2017.
visory Committee—Anesthesiologists, pulmonary medicine specialists, or other
experts who have specialized interests in ventilator support, pharmacology, phys-
iology, or the effects and complications of anesthesia.
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![28664 Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
administrative medicine, engineering, SUMMARY: In connection with promoting Staff, FDA will post your comment, as
biological and physical sciences, the use of innovative technologies, the well as any attachments, except for
statistics, and other related professions. Food and Drug Administration (FDA or information submitted, marked and
The nature of specialized training and Agency) is establishing a public docket identified, as confidential, if submitted
experience necessary to qualify the to invite discussion of issues related to as detailed in ‘‘Instructions.’’
nominee as an expert suitable for the adoption of continuous Instructions: All submissions received
appointment may include experience in manufacturing by the pharmaceutical must include the Docket No. FDA–
medical practice, teaching, and/or industry. 2017–N–2697 for ‘‘Submission of
research relevant to the field of activity Proposed Recommendations for
DATES: Submit electronic or written
of the panel. The particular needs at this Industry on Developing Continuous
comments by September 21, 2017.
time for each panel are listed in table 2 Manufacturing of Solid Dosage Drug
ADDRESSES: You may submit comments Products in Pharmaceutical
of this document. Members will be
as follows. Please note that late, Manufacturing; Establishment of a
invited to serve for terms of up to 4
untimely filed comments will not be Public Docket.’’ Received comments,
years.
considered. Electronic comments must those filed in a timely manner (see
III. Nomination Procedures be submitted on or before September 21, ADDRESSES), will be placed in the docket
Any interested person may nominate 2017. The https://www.regulations.gov and, except for those submitted as
one or more qualified individuals for electronic filing system will accept ‘‘Confidential Submissions,’’ publicly
membership on one or more of the comments until midnight Eastern Time viewable at https://www.regulations.gov
advisory panels or advisory committees. at the end of September 21, 2017. or at the Dockets Management Staff
Self-nominations are also accepted. Comments received by mail/hand between 9 a.m. and 4 p.m., Monday
Nominations must include a current, delivery/courier (for written/paper through Friday.
complete resume or curriculum vitae for submissions) will be considered timely • Confidential Submissions—To
each nominee, including current if they are postmarked or the delivery submit a comment with confidential
business address and/or home address, service acceptance receipt is on or information that you do not wish to be
telephone number, and email address if before that date. made publicly available, submit your
available. Nominations must also Electronic Submissions comments only as a written/paper
specify the advisory committee(s) for submission. You should submit two
Submit electronic comments in the copies total. One copy will include the
which the nominee is recommended.
following way: information you claim to be confidential
Nominations must also acknowledge
• Federal eRulemaking Portal: with a heading or cover note that states
that the nominee is aware of the
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
nomination unless self-nominated. FDA
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
will ask potential candidates to provide
Comments submitted electronically, Agency will review this copy, including
detailed information concerning such
including attachments, to https:// the claimed confidential information, in
matters related to financial holdings,
www.regulations.gov will be posted to its consideration of comments. The
employment, and research grants and/or
the docket unchanged. Because your second copy, which will have the
contracts to permit evaluation of
comment will be made public, you are claimed confidential information
possible sources of conflict of interest.
solely responsible for ensuring that your redacted/blacked out, will be available
This notice is issued under the
comment does not include any for public viewing and posted on
Federal Advisory Committee Act (5
confidential information that you or a https://www.regulations.gov. Submit
U.S.C. app. 2) and 21 CFR part 14,
third party may not wish to be posted, both copies to the Dockets Management
relating to advisory committees.
such as medical information, your or Staff. If you do not wish your name and
Dated: June 20, 2017. anyone else’s Social Security number, or contact information to be made publicly
Anna K. Abram, confidential business information, such available, you can provide this
Deputy Commissioner for Policy, Planning, as a manufacturing process. Please note information on the cover sheet and not
Legislation, and Analysis. that if you include your name, contact in the body of your comments and you
[FR Doc. 2017–13182 Filed 6–22–17; 8:45 am] information, or other information that must identify this information as
BILLING CODE 4164–01–P identifies you in the body of your ‘‘confidential.’’ Any information marked
comments, that information will be as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
DEPARTMENT OF HEALTH AND • If you want to submit a comment and other applicable disclosure law. For
HUMAN SERVICES with confidential information that you more information about FDA’s posting
do not wish to be made available to the of comments to public dockets, see 80
Food and Drug Administration public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
[Docket No. FDA–2017–N–2697] manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Submission of Proposed Docket: For access to the docket to
Recommendations for Industry on Written/Paper Submissions read background documents or the
Developing Continuous Manufacturing
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written/paper submissions as electronic and written/paper comments
of Solid Dosage Drug Products in follows: received, go to https://
Pharmaceutical Manufacturing; • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Establishment of a Public Docket written/paper submissions): Dockets docket number, found in brackets in the
AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and heading of this document, into the
HHS. Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
ACTION: Notice; establishment of docket;
• For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
request for comments.
submitted to the Dockets Management Rockville, MD 20852.
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Document Created: 2017-06-23 03:37:31
Document Modified: 2017-06-23 03:37:31
| 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 | Nominations received on or before August 22, 2017, will be given first consideration for membership on the Device Good Manufacturing Practice Advisory Committee and Panels of the Medical Devices Advisory Committee. Nominations received after August 22, 2017, will be considered for nomination to the committee as later vacancies occur. | |
| Contact | Regarding all nomination questions for membership, contact the following persons listed in table 1: | |
| FR Citation | 82 FR 28661 |
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