80_FR_20305 80 FR 20233 - Request for Nomination for Industry Representatives and Participation From Industry Organizations on Public Advisory Committees

80 FR 20233 - Request for Nomination for Industry Representatives and Participation From Industry Organizations on Public Advisory Committees

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range20233-20235
FR Document2015-08620

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015) 
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20233-20235]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Request for Nomination for Industry Representatives and 
Participation From Industry Organizations on Public Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any 
industry organizations interested in participating in the selection of 
nonvoting industry representatives to serve on its public advisory 
committees for the Center for Drug Evaluation and Research (CDER) 
notify FDA in writing. FDA is also requesting nominations for nonvoting 
industry representatives to serve on CDER's public advisory committees. 
A nominee may either be self-nominated or nominated by an organization 
to serve as a nonvoting industry representative. Nominations will be 
accepted for current vacancies effective with this notice.

DATES: Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests must send a letter stating that interest to FDA by May 15, 
2015, (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by May 15, 2015.

ADDRESSES: All statements of interest from interested industry 
organizations interested in participating in the selection process of 
nonvoting industry representative nominations should be

[[Page 20234]]

sent to Cicely Reese (see FOR FURTHER INFORMATION CONTACT). All 
nominations for nonvoting industry representatives may be submitted 
electronically by accessing the FDA Advisory Committee Membership 
Nomination Portal at 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 of an FDA advisory committee can 
also be obtained by visiting FDA's Web site http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, email: Cicely.Reese@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting 
industry representative to the following advisory committees:

I. CDER Advisory Committees

    A. Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology: Reviews and evaluates scientific, clinical, and technical 
issues related to the safety and effectiveness of drug products for use 
in the treatment of a broad spectrum of human diseases.
    B. Anesthetic and Analgesic Drug Products Advisory Committee 
(formerly Anesthetic and Life Support 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.
    C. Anti-Infective 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 
infectious diseases and disorders.
    D. Antiviral 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 
acquired immune deficiency syndrome (AIDS), HIV-related illnesses, and 
other viral, fungal, and mycobacterial infections. (Terminated February 
15, 2015).
    E. Arthritis 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 
arthritis, rheumatism, and related diseases.
    F. Bone, Reproductive, and Urologic Drugs Advisory Committee 
(formerly Advisory Committee for Reproductive Health Drugs): Reviews 
and evaluates available data on the safety and effectiveness of 
marketed and investigational human drugs for use in the practice of 
osteoporosis and metabolic bone disease, obstetrics, gynecology, 
urology, and related specialties.
    G. Cardiovascular and Renal Drugs Advisory Committee: Reviews and 
evaluates available data on the safety and effectiveness of marketed 
and investigational human drug products for use in the treatment of 
cardiovascular and renal disorders.
    H. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.
    I. Drug Safety and Risk Management Advisory Committee: Reviews and 
evaluates information on risk management, risk communication, and 
quantitative evaluation of spontaneous reports for drugs for human use.
    J. Endocrinologic and Metabolic 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 endocrine and metabolic disorders.
    K. 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.
    L. Medical Imaging Drugs Advisory Committee: Reviews and evaluates 
available 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.
    M. Nonprescription Drugs Advisory Committee: Reviews and evaluates 
available data concerning the safety and effectiveness of over-the-
counter (nonprescription) human drug products for use in the treatment 
of a broad spectrum of human symptoms and diseases.
    N. Oncologic 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 cancer.
    O. Peripheral and Central Nervous System 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 neurologic diseases.
    P. Pharmacy Compounding Advisory Committee: Provides advice on 
scientific, technical, and medical issues concerning drug compounding.
    Q. Psychopharmacologic Drugs Advisory Committee: Reviews and 
evaluates available data concerning the safety and effectiveness of 
marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.
    R. 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.

II. Selection Procedure

    Any industry organization interested in participating in the 
selection of an appropriate nonvoting member to represent industry 
interests should send a letter stating that interest to the FDA contact 
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of 
this document (see DATES). Within the subsequent 30 days, FDA will send 
a letter to each organization that has expressed an interest, attaching 
a complete list of all such organizations and a list of all nominees 
along with their current resumes. The letter will also state that it is 
the responsibility of the interested organizations to confer with one 
another and to select a candidate, within 60 days after the receipt of 
the FDA letter, to serve as the nonvoting member to represent industry 
interests for the committee. The interested organizations are not bound 
by the list of nominees in selecting a candidate. However, if no 
individual is selected within 60 days, the Commissioner will select the 
nonvoting member to represent industry interests.

III. Application Procedure

    Individuals may self-nominate and/or an organization may nominate 
one or more individuals to serve as a nonvoting industry 
representative. Contact information, a current curriculum vitae, and 
the name of the committee of interest should be sent to the FDA 
Advisory Committee Membership Nomination Portal (see ADDRESSES) within 
30 days of publication of this

[[Page 20235]]

document (see DATES). FDA will forward all nominations to the 
organizations expressing interest in participating in the selection 
process for the committee. (Persons who nominate themselves as 
nonvoting industry representatives will not participate in the 
selection process).
    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.
    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 9, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-08620 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20233 Dated: March 8, 2015. www.aaps.org/Meetings_and_ discussion of cutting edge science in Leslie Kux, Professional_Development/Conference_ transporters among scientists from Associate Commissioner for Policy. Mini_Sites/AAPS_WS_Transporters15/ academia, industry, and regulatory [FR Doc. 2015–08618 Filed 4–14–15; 8:45 am] Register/. The cost of registration is as agencies. BILLING CODE 4164–01–P follows: • To develop a mutual understanding on what needs to be done in transporter AAPS Member .......................... $1,815 research and how to translate DEPARTMENT OF HEALTH AND Nonmember .............................. 2,190 knowledge obtained from the bench to HUMAN SERVICES Government .............................. 675 bedside. Academic .................................. 880 • To facilitate and enhance Food and Drug Administration Student ..................................... 110 translational applications of new development in transporter research in [Docket No. FDA–2015–N–0001] The registration fee will be waived for drug development and regulatory 50 FDA employees. If you need special review of new therapeutics. Joint Workshop on Drug Transporters accommodations because of a disability, in Absorption, Distribution, please contact AAPS at registration@ Dated: April 8, 2015. Metabolism, and Excretion: From the aaps.org. Onsite registration on the day Leslie Kux, Bench to the Bedside of the workshop will be available. Associate Commissioner for Policy. AGENCY: Food and Drug Administration, Additional Information About the [FR Doc. 2015–08614 Filed 4–14–15; 8:45 am] HHS. Workshop: The workshop agenda and BILLING CODE 4164–01–P ACTION: Notice of public workshop. additional background materials will be accessible at http://www.fda.gov/Drugs/ The Food and Drug Administration NewsEvents/ucm439157.htm to all DEPARTMENT OF HEALTH AND (FDA) is announcing a public workshop registrants. HUMAN SERVICES entitled ‘‘Drug Transporters in SUPPLEMENTARY INFORMATION: Absorption, Distribution, Metabolism, Food and Drug Administration and Excretion (ADME): From the Bench I. Background [Docket No. FDA–2015–N–0001] to the Bedside.’’ The public workshop is Transporters serve an important role an American Association of in the ADME of drugs, and in turn could Request for Nomination for Industry Pharmaceutical Scientists/International affect their safety or efficacy. The Representatives and Participation Transporter Consortium (AAPS/ITC) AAPS/ITC joint transporter workshop in From Industry Organizations on Public Joint Workshop, cosponsored with 2015 aims to continue on the success of Advisory Committees AAPS, the American Society for Clinical preceding AAPS workshops on Drug Pharmacology and Therapeutics, and AGENCY: Food and Drug Administration, Transporters meetings (2003, 2005, HHS. the European Federation for 2007, 2009, 2011, 2013) and ITC Pharmaceutical Sciences. The goals of ACTION: Notice. transporter workshops (2008 and 2012) this public workshop are to provide an to provide an opportunity for scientists SUMMARY: The Food and Drug opportunity for scientists in academia, in academia, industry, and regulatory Administration (FDA) is requesting that industry, and regulatory agencies to agencies to exchange ideas about the any industry organizations interested in exchange ideas about the cutting edge cutting-edge science. Key areas of focus participating in the selection of science in transporters, and to facilitate will include the following: nonvoting industry representatives to and enhance translational applications • Transporter tools of the future (e.g., serve on its public advisory committees of new development in transporter organs-on-a-chip, humanized mouse for the Center for Drug Evaluation and research in drug development and models, and transporter imaging); Research (CDER) notify FDA in writing. regulatory review of new therapeutics. • Interplay of drug metabolism and FDA is also requesting nominations for Date and Time: The public workshop transporters; nonvoting industry representatives to will be held on April 20, 2015, from • ‘‘State of the art’’ sessions on: serve on CDER’s public advisory 8:15 a.m. to 7 p.m.; April 21, 2015, from Æ Emerging transporters, committees. A nominee may either be 8 a.m. to 6:30 p.m.; and April 22, 2015, Æ Endogenous biomarkers to assess self-nominated or nominated by an from 8 a.m. to 3:45 p.m. transporter-mediated drug efficacy and organization to serve as a nonvoting Location: The public workshop will toxicity or to predict drug-drug industry representative. Nominations be held at the Renaissance Baltimore interactions, and will be accepted for current vacancies Harborplace Hotel, 202 East Pratt St., Æ Quantitative transporter proteomics effective with this notice. Baltimore, MD 21202. The hotel’s phone in translational drug metabolism and number is 410–547–1200. DATES: Any industry organization pharmacokinetics; Contacts: FDA: Lei Zhang, Food and • ‘‘Hot Topics’’ in the translation of interested in participating in the Drug Administration, Center for Drug transporter data to the clinic; selection of an appropriate nonvoting Evaluation and Research, 10903 New • Prospective transporter substrate member to represent industry interests Hampshire Ave., Bldg. 51, Rm. 3196, modeling; and must send a letter stating that interest to Silver Spring, MD 20993, 301–796– • Review of comments related to FDA by May 15, 2015, (see sections I 1635, email: leik.zhang@fda.hhs.gov. transporters following recent guidances and II of this document for further AAPS: For questions related to this issued from the regulatory agencies, details). Concurrently, nomination tkelley on DSK3SPTVN1PROD with NOTICES event, please contact AAPS at including FDA, European Medicines materials for prospective candidates registration@aaps.org. Agency, and Pharmaceuticals and should be sent to FDA by May 15, 2015. Registration: Workshop information Medical Devices Agency (Japan). ADDRESSES: All statements of interest and the registration link are posted at from interested industry organizations the AAPS meetings and professional II. Goals and Objectives interested in participating in the development conference site. To register • To provide a forum for open selection process of nonvoting industry for the workshop, please visit http:// interchange, dissemination, and representative nominations should be VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1

20234 Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices sent to Cicely Reese (see FOR FURTHER of arthritis, rheumatism, and related investigational human drug products for INFORMATION CONTACT). All nominations diseases. use in the treatment of cancer. for nonvoting industry representatives F. Bone, Reproductive, and Urologic O. Peripheral and Central Nervous may be submitted electronically by Drugs Advisory Committee (formerly System Drugs Advisory Committee: accessing the FDA Advisory Committee Advisory Committee for Reproductive Reviews and evaluates available data Membership Nomination Portal at Health Drugs): Reviews and evaluates concerning the safety and effectiveness https://www.accessdata.fda.gov/scripts/ available data on the safety and of marketed and investigational human FACTRSPortal/FACTRS/index.cfm or by effectiveness of marketed and drug products for use in the treatment mail to Advisory Committee Oversight investigational human drugs for use in of neurologic diseases. and Management Staff, Food and Drug the practice of osteoporosis and P. Pharmacy Compounding Advisory Administration, 10903 New Hampshire metabolic bone disease, obstetrics, Committee: Provides advice on Ave., Bldg. 32, Rm. 5103, Silver Spring, gynecology, urology, and related scientific, technical, and medical issues MD 20993–0002. Information about specialties. concerning drug compounding. becoming a member of an FDA advisory G. Cardiovascular and Renal Drugs Q. Psychopharmacologic Drugs committee can also be obtained by Advisory Committee: Reviews and Advisory Committee: Reviews and visiting FDA’s Web site http:// evaluates available data on the safety evaluates available data concerning the www.fda.gov/AdvisoryCommittees/ and effectiveness of marketed and safety and effectiveness of marketed and default.htm. investigational human drug products for investigational human drug products for use in the treatment of cardiovascular use in the practice of psychiatry and FOR FURTHER INFORMATION CONTACT: related fields. Cicely Reese, Center for Drug Evaluation and renal disorders. R. Pulmonary-Allergy Drugs Advisory and Research, Food and Drug H. Dermatologic and Ophthalmic Committee: Reviews and evaluates Administration, 10903 New Hampshire Drugs Advisory Committee: Reviews available data concerning the safety and Ave., Bldg. 31, Rm. 2417, Silver Spring, and evaluates available data concerning effectiveness of marketed and MD 20993–0002, 301–796–9001, email: the safety and effectiveness of marketed investigational human drug products for Cicely.Reese@fda.hhs.gov. and investigational human drug use in the treatment of pulmonary SUPPLEMENTARY INFORMATION: The products for use in the treatment of disease and diseases with allergic and/ Agency intends to add a nonvoting dermatologic and ophthalmic disorders. or immunologic mechanisms. industry representative to the following I. Drug Safety and Risk Management advisory committees: Advisory Committee: Reviews and II. Selection Procedure evaluates information on risk Any industry organization interested I. CDER Advisory Committees management, risk communication, and in participating in the selection of an A. Advisory Committee for quantitative evaluation of spontaneous appropriate nonvoting member to Pharmaceutical Science and Clinical reports for drugs for human use. represent industry interests should send Pharmacology: Reviews and evaluates J. Endocrinologic and Metabolic Drugs a letter stating that interest to the FDA scientific, clinical, and technical issues Advisory Committee: Reviews and contact (see FOR FURTHER INFORMATION related to the safety and effectiveness of evaluates available data concerning the CONTACT) within 30 days of publication drug products for use in the treatment safety and effectiveness of marketed and of this document (see DATES). Within the of a broad spectrum of human diseases. investigational human drug products for subsequent 30 days, FDA will send a B. Anesthetic and Analgesic Drug use in the treatment of endocrine and letter to each organization that has Products Advisory Committee (formerly metabolic disorders. expressed an interest, attaching a Anesthetic and Life Support Drugs K. Gastrointestinal Drugs Advisory complete list of all such organizations Advisory Committee): Reviews and Committee: Reviews and evaluates and a list of all nominees along with evaluates available data concerning the available data concerning the safety and their current resumes. The letter will safety and effectiveness of marketed and effectiveness of marketed and also state that it is the responsibility of investigational human drug products for investigational human drug products for the interested organizations to confer use in anesthesiology and surgery. use in the treatment of gastrointestinal with one another and to select a C. Anti-Infective Drugs Advisory diseases. candidate, within 60 days after the Committee: Reviews and evaluates L. Medical Imaging Drugs Advisory receipt of the FDA letter, to serve as the available data concerning the safety and Committee: Reviews and evaluates nonvoting member to represent industry effectiveness of marketed and available data concerning the safety and interests for the committee. The investigational human drug products for effectiveness of marketed and interested organizations are not bound use in the treatment of infectious investigational human drug products for by the list of nominees in selecting a diseases and disorders. use in diagnostic and therapeutic candidate. However, if no individual is D. Antiviral Drugs Advisory procedures using radioactive selected within 60 days, the Committee: Reviews and evaluates pharmaceuticals and contrast media Commissioner will select the nonvoting available data concerning the safety and used in diagnostic radiology. member to represent industry interests. effectiveness of marketed and M. Nonprescription Drugs Advisory investigational human drug products for Committee: Reviews and evaluates III. Application Procedure use in the treatment of acquired available data concerning the safety and Individuals may self-nominate and/or immune deficiency syndrome (AIDS), effectiveness of over-the-counter an organization may nominate one or HIV-related illnesses, and other viral, (nonprescription) human drug products more individuals to serve as a nonvoting tkelley on DSK3SPTVN1PROD with NOTICES fungal, and mycobacterial infections. for use in the treatment of a broad industry representative. Contact (Terminated February 15, 2015). spectrum of human symptoms and information, a current curriculum vitae, E. Arthritis Advisory Committee: diseases. and the name of the committee of Reviews and evaluates available data N. Oncologic Drugs Advisory interest should be sent to the FDA concerning the safety and effectiveness Committee: Reviews and evaluates Advisory Committee Membership of marketed and investigational human available data concerning the safety and Nomination Portal (see ADDRESSES) drug products for use in the treatment effectiveness of marketed and within 30 days of publication of this VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1

Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20235 document (see DATES). FDA will forward the SUPPLEMENTARY INFORMATION section and academic settings by providing all nominations to the organizations of this notice. access to de-identified electronic expressing interest in participating in FOR FURTHER INFORMATION CONTACT: healthcare data and computing the selection process for the committee. Patrick Archdeacon, Food and Drug resources through the IMEDS Research (Persons who nominate themselves as Administration, Bldg. 51 Rm.6314, Laboratory. nonvoting industry representatives will 10903 New Hampshire Ave., Silver C. Eligibility Information not participate in the selection process). Spring, MD 20993–0002, 301–796–3952; FDA seeks to include the views of or Vieda Hubbard, Division of Eligibility is limited to the Reagan- women and men, members of all racial Acquisition Support and Grants (HFA– Udall Foundation. The Reagan-Udall and ethnic groups, and individuals with 500), Food and Drug Administration, Foundation has established the IMEDS- and without disabilities on its advisory 5630 Fishers Lane, Rockville, MD Methods program, which is uniquely committees and, therefore, encourages 20857, 240–402–7588. positioned to develop the new nominations of appropriately qualified For more information on this funding methodologies required for FDA to candidates from these groups. opportunity announcement (FOA) and conduct effective active post market This notice is issued under the to obtain detailed requirements, please safety surveillance of medical products Federal Advisory Committee Act (5 refer to the full FOA located at: http:// using large electronic health care data. U.S.C. app. 2) and 21 CFR part 14, www.grants.gov/. The IMEDS organization has developed relating to advisory committees. SUPPLEMENTARY INFORMATION: a network of statisticians, Dated: April 9, 2015. epidemiologists, data scientists, and I. Funding Opportunity Description clinicians who have experience Jill Hartzler Warner, RFA–FD–15–010 93.103 operating in both the IMEDS research Associate Commissioner for Special Medical A. Background laboratory and also familiarity with the Programs. Sentinel Distributed Database. In [FR Doc. 2015–08620 Filed 4–14–15; 8:45 am] Section 905 of the Food and Drug addition, through the Reagan-Udall BILLING CODE 4164–01–P Administration Amendments Act of Foundation public-private partnership, 2007 (Pub. L. 110–85) mandates FDA to the IMEDS-Methods program has a develop an enhanced ability to monitor unique ability to convene FDA, patients, DEPARTMENT OF HEALTH AND the safety of drugs after these products academics, government, and industry so HUMAN SERVICES reach the market. In response to this that the findings and tools developed mandate, FDA launched its Sentinel through its research agenda will be Food and Drug Administration Initiative, a long-term program designed promulgated and adopted. to build and implement an electronic [Docket No. FDA–2015–N–1083] system for monitoring the safety of II. Award Information/Funds Available medical products in the post market A. Award Amount Innovations in Medical Evidence setting. FDA has already created Development and Surveillance- FDA/CDER intends to fund up to significant infrastructure on which to Methods Research Agenda $1,000,000 in fiscal year 2015 in operate such a system: Through its AGENCY: Food and Drug Administration, Mini-Sentinel pilot, a distributed support of this program project. It is HHS. database with access to more than 150 anticipated that only one award will be million patient records has been created made, not to exceed $1,000,000 (direct ACTION: Notice. (the Sentinel Distributed Database). In plus indirect) for total costs. SUMMARY: The Food and Drug order to optimally leverage these data, B. Length of Support Administration (FDA) is announcing the however, new analytic methodologies availability of grant funds for the will be required. IMEDS-Methods is a There is a one year period of support of Center for Drug Evaluation program within the Reagan-Udall performance beginning on June 15, 2015 and Research (CDER). The goal of the Foundation that supports FDA’s or the date of award. CDER is to support the development of scientific mission of serving public III. Electronic Application, appropriate methodologies to conduct health needs by initiating and Registration, and Submission medical product safety surveillance in facilitating research into the methods of large electronic databases. Innovations safety evaluation in large databases. Only one electronic application will in Medical Evidence Development and IMEDS-Methods aims to improve the be accepted. To submit an electronic Surveillance (IMEDS)-Methods is a tools for conducting post-marketing application in response to this FOA, the program within the Reagan-Udall safety surveillance using automated applicant should first review the full Foundation that supports FDA’s healthcare data and to foster their announcement located at http:// scientific mission of serving public adoption. www.grants.gov/. (FDA has verified the health needs by initiating and Web site addresses throughout this B. Research Objectives document, but FDA is not responsible facilitating research into the methods of safety evaluation in large databases. IMEDS plans to conduct methods for any subsequent changes to the Web research in five core areas: (1) sites after this document publishes in DATES: 1. The application due date is the Federal Register.) Addressing bias in estimates from June 15, 2015. observational studies; (2) better For the electronically submitted 2. The anticipated start date is July 15, understanding uses and limitations of application, the following steps are 2015. tkelley on DSK3SPTVN1PROD with NOTICES the data; (3) applying lessons learned required. 3. The opening date is April 13, 2015. from earlier IMEDS projects to FDA • Step 1: Obtain a Dun and Bradstreet 4. The expiration date is June 16, surveillance activities; (4) expanding the (DUNS) Number 2015. surveillance question to continuous • Step 2: Register With System for ADDRESSES: Submit the electronic risk/benefit assessment; and (5) Award Management (SAM) application to: http://www.grants.gov. continuing to support qualified • Step 3: Obtain Username & For more information, see section III of investigators in industry, government, Password VerDate Sep<11>2014 17:29 Apr 14, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1


Document Created: 2015-12-18 11:13:15
Document Modified: 2015-12-18 11:13:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAny industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by May 15, 2015, (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by May 15, 2015.
ContactCicely Reese, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, email: Cicely.R[email protected]
FR Citation80 FR 20233 
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