81 FR 37608 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 112 (June 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 112 (June 10, 2016)
| Page Range | 37608-37611 | |
| FR Document | 2016-13733 |
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)] [Notices] [Pages 37608-37611] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13733] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-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 11, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by July 11, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through August 31, 2016. 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: 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 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 in the SUPPLEMENTARY INFORMATION section: SUPPLEMENTARY INFORMATION: I. Background 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 (see table 1 for Contact Person). Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Janie Kim, Center for Biologics Evaluation Allergenic Products Advisory and Research, Food and Drug Committee. Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993-0002, Phone: 301-796-9016, Email: [email protected]. [[Page 37609]] Shanika Craig, Center for Devices and Anesthesiology and Radiological Health, Food and Drug Respiratory Therapy Devices Administration, 10903 New Hampshire Ave., Panel. Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, Phone: 301-796-6639, Email: [email protected]. Patricio Garcia, Center for Devices and Gastroenterology and Urology Radiological Health, Food and Drug Devices Panel; General and Administration, 10903 New Hampshire Ave., Plastic Surgery Devices Bldg. 66, Rm. 1611, Silver Spring, MD Panel; Neurological Devices 20993-0002, Phone: 301-796-6875, Email: Panel. [email protected]. Natasha Facey, Center for Devices and Ophthalmic Devices Panel. Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3354, Silver Spring, MD 20993-0002, Phone: 301-796-5290, Email: [email protected]. Evella Washington, Center for Devices and Molecular and Clinical Radiological Health, Food and Drug Genetics Devices Panel. Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993-0002, Phone: 301-796-6683, 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. 2430, Silver Spring, MD 20993-0002, Phone: 301-796-0889, Email: [email protected]. Jennifer Shepherd, Center for Drug Medical Imaging Advisory Evaluation and Research, Food and Drug Committee; Pharmaceutical Administration, 10903 New Hampshire Ave., Science and Clinical Bldg. 31, Rm. 2434, Silver Spring, MD Pharmacology Advisory 20993-0002, Phone: 301-796-4043, Email: Committee. [email protected]. ------------------------------------------------------------------------ Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate ------------------------------------------------------------------------ Committee/panel/areas of Approximate date expertise needed Type of vacancy needed ------------------------------------------------------------------------ Allergenic Products Advisory 1--Voting......... August 31, 2016. Committee--Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. Anesthesiology and Respiratory 1--Non-Voting..... Immediately. Therapy Devices Panel-- Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia. Gastroenterology and Urology 1--Non-Voting..... Immediately. Devices Panel Science Advisory Board to the National Center for Toxicological Research-- Knowledgeable in the fields related to toxicological research. General and Plastic Surgery 1--Non-Voting..... Immediately. Devices Panel--Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians. Neurological Devices Panel-- 1--Non-Voting..... Immediately. Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians. Ophthalmic Devices Panel-- 1--Non-Voting..... Immediately. Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical trial design, quality of life assessment, electrophysiology, low vision rehabilitation, and biostatistics. Molecular and Clinical Genetics 1--Non-Voting..... Immediately. Devices Panel--Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics as well as ancillary fields of study will be considered. Gastrointestinal Drugs Advisory 1--Voting......... June 30, 2016. Committee--Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Medical Imaging Advisory 1--Voting......... June 30, 2016. Committee--Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics and related specialties. Pharmaceutical Science and 1--Voting......... Immediately. Clinical Pharmacology Advisory Committee--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. ------------------------------------------------------------------------ II. Functions and General Description of the Committee Duties A. Allergenic Products Advisory Committee Reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease as well as the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the product; on clinical and laboratory studies of such products; on amendments or revisions to regulations governing the manufacture, testing, and licensing of allergenic biological products; and on the quality and relevance of FDA's research programs. [[Page 37610]] 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, 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. C. 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. D. 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. E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Provide advice on scientific and technical issues concerning the safety 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. III. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and 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. IV. 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 resume. 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. V. 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 resume 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 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. [[Page 37611]] Dated: June 3, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-13733 Filed 6-9-16; 8:45 am] BILLING CODE 4164-01-P
![37608 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices
approval phase. These periods of time 305), Food and Drug Administration, prospective candidates should be sent to
were derived from the following dates: 5630 Fishers Lane, Rm. 1061, Rockville, FDA (see ADDRESSES) by July 11, 2016.
1. The date an exemption under MD 20852. Nominations will be accepted for
section 505(i) of the Federal Food, Drug, Dated: June 3, 2016. current vacancies and for those that will
and Cosmetic Act (the FD&C Act) (21 Leslie Kux, or may occur through August 31, 2016.
U.S.C. 355(i)) became effective: ADDRESSES: All statements of interest
Associate Commissioner for Policy.
December 9, 2002. The applicant claims from consumer organizations interested
[FR Doc. 2016–13796 Filed 6–9–16; 8:45 am]
December 14, 2002, as the date the in participating in the selection process
BILLING CODE 4164–01–P
investigational new drug application and consumer representative
(IND) became effective. However, FDA nominations should be submitted
records indicate that the IND effective electronically to kimberly.hamilton@
DEPARTMENT OF HEALTH AND
date was December 9, 2002, which was fda.hhs.gov, by mail to Advisory
HUMAN SERVICES
the first date after receipt of the IND that Committee Oversight and Management
the investigational studies were allowed Food and Drug Administration Staff, 10903 New Hampshire Ave., Bldg.
to proceed. 32, Rm. 5103, Silver Spring, MD 20993–
2. The date the application was [Docket No. FDA–2016–N–0001]
0002, or by FAX: 301–847–8640.
initially submitted with respect to the
Request for Nominations for Consumer representative nominations
human drug product under section
Individuals and Consumer should be submitted electronically by
505(b) of the FD&C Act: April 10, 2012.
Organizations for Advisory logging into the FDA Advisory
FDA has verified the applicant’s claim
Committees Committee Membership Nomination
that the new drug application (NDA) for
POMALYST (NDA 204026) was initially AGENCY: Food and Drug Administration, Portal: https://www.accessdata.fda.gov/
submitted on April 10, 2012. HHS. scripts/FACTRSPortal/FACTRS/
3. The date the application was index.cfm, by mail to Advisory
ACTION: Notice.
approved: February 8, 2013. FDA has Committee Oversight and Management
verified the applicant’s claim that NDA SUMMARY: The Food and Drug Staff, 10903 New Hampshire Ave., Bldg.
204026 was approved on February 8, Administration (FDA) is requesting that 32, Rm. 5103, Silver Spring, MD 20993–
2013. any consumer organizations interested 0002, or by FAX: 301–847–8640.
This determination of the regulatory in participating in the selection of Additional information about becoming
review period establishes the maximum voting and/or nonvoting consumer a member on an FDA advisory
potential length of a patent extension. representatives to serve on its advisory committee can also be obtained by
However, the USPTO applies several committees or panels notify FDA in visiting FDA’s Web site at http://
statutory limitations in its calculations writing. FDA is also requesting www.fda.gov/AdvisoryCommittees/
of the actual period for patent extension. nominations for voting and/or default.htm.
In its applications for patent extension, nonvoting consumer representatives to
FOR FURTHER INFORMATION CONTACT: For
this applicant seeks 5 years or 241 days serve on advisory committees and/or
questions relating to participation in the
of patent term extension. panels for which vacancies currently
selection process: Kimberly Hamilton,
exist or are expected to occur in the near
III. Petitions Advisory Committee Oversight and
future. Nominees recommended to serve
Management Staff (ACOMS), Food and
Anyone with knowledge that any of as a voting or nonvoting consumer
Drug Administration, 10903 New
the dates as published are incorrect may representative may be self-nominated or
Hampshire Ave., Bldg. 32, Rm. 5103,
submit either electronic or written may be nominated by a consumer
Silver Spring, MD 20993–0002, 301–
comments and ask for a redetermination organization.
FDA seeks to include the views of 796–8220 email: kimberly.hamilton@
(see DATES). Furthermore, any interested
women and men, members of all racial fda.hhs.gov.
person may petition FDA for a
determination regarding whether the and ethnic groups, and individuals with For questions relating to specific
applicant for extension acted with due and without disabilities on its advisory advisory committees or panels, contact
diligence during the regulatory review committees and, therefore, encourages the appropriate Contact Person listed in
period. To meet its burden, the petition nominations of appropriately qualified table 1 in the SUPPLEMENTARY
candidates from these groups. INFORMATION section:
must be timely (see DATES) and contain
sufficient facts to merit an FDA DATES: Any consumer organization SUPPLEMENTARY INFORMATION:
investigation. (See H. Rept. 857, part 1, interested in participating in the
I. Background
98th Cong., 2d sess., pp. 41–42, 1984.) selection of an appropriate voting or
Petitions should be in the format nonvoting member to represent FDA is requesting that any consumer
specified in 21 CFR 10.30. consumer interests on an FDA advisory organizations interested in participating
Submit petitions electronically to committee or panel may send a letter or in the selection of voting and/or
http://www.regulations.gov at Docket email stating that interest to FDA (see nonvoting consumer representatives to
No. FDA–2013–S–0610. Submit written ADDRESSES) by July 11, 2016, for serve on its advisory committees or
petitions (two copies are required) to the vacancies listed in this notice. panels notify FDA in writing (see table
Division of Dockets Management (HFA– Concurrently, nomination materials for 1 for Contact Person).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel
Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Allergenic Products Advisory Committee.
Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993–0002, Phone: 301–796–9016,
Email: Janie.Kim@fda.hhs.gov.
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![Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37611
Dated: June 3, 2016. as a manufacturing process. Please note information as ‘‘confidential.’’ Any
Jill Hartzler Warner, that if you include your name, contact information marked as ‘‘confidential’’
Associate Commissioner for Special Medical information, or other information that will not be disclosed except in
Programs. identifies you in the body of your accordance with 21 CFR 10.20 and other
[FR Doc. 2016–13733 Filed 6–9–16; 8:45 am] comments, that information will be applicable disclosure law. For more
BILLING CODE 4164–01–P posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
with confidential information that you 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: http://www.fda.gov/
HUMAN SERVICES public, submit the comment as a regulatoryinformation/dockets/
written/paper submission and in the default.htm.
Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2014–E–2341] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Determination of Regulatory Review received, go to http://
Period for Purposes of Patent Submit written/paper submissions as www.regulations.gov and insert the
Extension; TANZEUM follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for
heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Division of
‘‘Search’’ box and follow the prompts
HHS. Dockets Management (HFA–305), Food
and/or go to the Division of Dockets
ACTION: Notice. and Drug Administration, 5630 Fishers
Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
1061, Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments
Administration (FDA) has determined submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT:
the regulatory review period for Management, FDA will post your Beverly Friedman, Office of Regulatory
TANZEUM and is publishing this notice comment, as well as any attachments, Policy, Food and Drug Administration,
of that determination as required by except for information submitted, 10903 New Hampshire Ave. Bldg. 51,
law. FDA has made the determination marked and identified, as confidential, Rm. 6250, Silver Spring, MD 20993,
because of the submission of an if submitted as detailed in 301–796–3600.
application to the Director of the U.S. ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
Patent and Trademark Office (USPTO), Instructions: All submissions received
Department of Commerce, for the I. Background
must include the Docket No. FDA–
extension of a patent which claims that 2014–E–2341 The Drug Price Competition and
human biological product. For Determination of Regulatory Patent Term Restoration Act of 1984
DATES: Anyone with knowledge that any Review Period for Purposes of Patent (Pub. L. 98–417) and the Generic
of the dates as published (in the Extension; TANZEUM. Received Animal Drug and Patent Term
SUPPLEMENTARY INFORMATION section) are comments will be placed in the docket Restoration Act (Pub. L. 100–670)
incorrect may submit either electronic and, except for those submitted as generally provide that a patent may be
or written comments and ask for a ‘‘Confidential Submissions,’’ publicly extended for a period of up to 5 years
redetermination by August 9, 2016. viewable at http://www.regulations.gov so long as the patented item (human
Furthermore, any interested person may or at the Division of Dockets drug product, animal drug product,
petition FDA for a determination Management between 9 a.m. and 4 p.m., medical device, food additive, or color
regarding whether the applicant for Monday through Friday. additive) was subject to regulatory
extension acted with due diligence • Confidential Submissions—To review by FDA before the item was
during the regulatory review period by submit a comment with confidential marketed. Under these acts, a product’s
December 7, 2016. See ‘‘Petitions’’ in information that you do not wish to be regulatory review period forms the basis
the SUPPLEMENTARY INFORMATION section made publicly available, submit your for determining the amount of extension
for more information. comments only as a written/paper an applicant may receive.
ADDRESSES: You may submit comments submission. You should submit two A regulatory review period consists of
as follows: copies total. One copy will include the two periods of time: A testing phase and
information you claim to be confidential an approval phase. For human
Electronic Submissions with a heading or cover note that states biological products, the testing phase
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS begins when the exemption to permit
following way: CONFIDENTIAL INFORMATION’’. The the clinical investigations of the
• Federal eRulemaking Portal: http:// Agency will review this copy, including biological becomes effective and runs
www.regulations.gov. Follow the the claimed confidential information, in until the approval phase begins. The
instructions for submitting comments. its consideration of comments. The approval phase starts with the initial
Comments submitted electronically, second copy, which will have the submission of an application to market
including attachments, to http:// claimed confidential information the human biological product and
www.regulations.gov will be posted to redacted/blacked out, will be available continues until FDA grants permission
the docket unchanged. Because your for public viewing and posted on http:// to market the biological product.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
comment will be made public, you are www.regulations.gov. Submit both Although only a portion of a regulatory
solely responsible for ensuring that your copies to the Division of Dockets review period may count toward the
comment does not include any Management. If you do not wish your actual amount of extension that the
confidential information that you or a name and contact information to be Director of USPTO may award (for
third party may not wish to be posted, made publicly available, you can example, half the testing phase must be
such as medical information, your or provide this information on the cover subtracted as well as any time that may
anyone else’s Social Security number, or sheet and not in the body of your have occurred before the patent was
confidential business information, such comments and you must identify this issued), FDA’s determination of the
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Document Created: 2018-02-08 07:35:36
Document Modified: 2018-02-08 07:35:36
| 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 | 81 FR 37608 |
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