80_FR_21322 80 FR 21248 - Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop

80 FR 21248 - Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 74 (April 17, 2015)

Page Range21248-21249
FR Document2015-08846

Federal Register, Volume 80 Issue 74 (Friday, April 17, 2015) 
[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21248-21249]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08846]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Addressing Inadequate Information on Important Health Factors in 
Pharmacoepidemiology Studies Relying on Healthcare Databases; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored by FDA and the University of Maryland Center for 
Excellence in Regulatory Science and Innovation, entitled 
``Methodological Considerations to Address Unmeasured Information About 
Important Health Factors in Pharmacoepidemiology Studies that Rely on 
Electronic Healthcare Databases to Evaluate the Safety of Regulated 
Pharmaceutical Products in the Postapproval Setting.'' The purpose of 
the public workshop is to engage in constructive dialogue among 
regulators, academicians, pharmaceutical industry, clinicians, other 
stakeholders and the general public on potential strategies to improve 
availability of information on important health factors in 
pharmacoepidemiology studies that rely on electronic healthcare 
databases to evaluate the safety of pharmaceutical products in the 
postapproval setting. Electronic healthcare databases are increasingly 
being used in the postapproval assessment of the safety profile of 
pharmaceutical drug products.
    Date and Time: The public workshop will be held on May 4, 2015, 8 
a.m. to 5 p.m.
    Location: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Leslie Wheelock, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4345, 
Silver Spring, MD, 301-796-4580, FAX: 301-847-8106, 
leslie.wheelock@fda.hhs.gov.
    Registration: Submit your online registration information 
(including name, title, firm name, address, telephone and fax numbers) 
by April 30, 2015, at: http://www.pharmacy.umaryland.edu/centers/cersievents/biasinbigdata/. There is no registration fee for University 
of Maryland faculty, students, and staff, University of Maryland Center 
for Excellence in Regulatory Science and Innovation Industrial 
Consortia Members, and Federal Government employees. There is a $50.00 
registration fee for all other participants. Early registration is 
recommended because seating is limited. There will be no onsite 
registration.
    If you need special accommodations due to a disability, please 
contact Leslie Wheelock (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: 
    In many instances, these resources allow for the timely evaluation 
of drug-related adverse events since data on healthcare utilized by a 
large number of individuals are readily available. However, because 
these data are typically collected for administrative purposes, 
information on important health factors necessary to evaluate drug-
outcome relationship may be

[[Page 21249]]

absent or incomplete in these data sources. Examples include tobacco/
smoking use and history, alcohol consumption, weight and height, 
patient and family medical history, or use of over-the-counter 
medications. Incomplete capture or the absence of this information can 
result in biased or uncertain estimates for the drug-outcome 
relationship of interest leading to inadequate evaluation of the safety 
profile of prescription drug products.
    Webcast: Please be advised that as soon as possible after a Webcast 
of the public workshop is available, it will be accessible at: http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm429136.htm.

    Dated: April 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08846 Filed 4-16-15; 8:45 am]
 BILLING CODE 4164-01-P

21248 Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices and/or amino acid supplementation during the regulatory review period by availability of information on important alone. Subsequent to this approval, the October 14, 2015. To meet its burden, health factors in pharmacoepidemiology USPTO received a patent term the petition must contain sufficient facts studies that rely on electronic restoration application for RAVICTI to merit an FDA investigation. (See H. healthcare databases to evaluate the (U.S. Patent No. 5,968,979) from Rept. 857, part 1, 98th Cong., 2d sess., safety of pharmaceutical products in the Hyperion Therapeutics, Inc., and the pp. 41–42, 1984.) Petitions should be in postapproval setting. Electronic USPTO requested FDA’s assistance in the format specified in 21 CFR 10.30. healthcare databases are increasingly determining this patent’s eligibility for Interested persons may submit to the being used in the postapproval patent term restoration. In a letter dated Division of Dockets Management (see assessment of the safety profile of May 2, 2014, FDA advised the USPTO ADDRESSES) electronic or written pharmaceutical drug products. that this human drug product had comments and written or electronic Date and Time: The public workshop undergone a regulatory review period petitions. It is only necessary to send will be held on May 4, 2015, 8 a.m. to and that the approval of RAVICTI one set of comments. Identify comments 5 p.m. represented the first permitted with the docket number found in Location: The public workshop will commercial marketing or use of the brackets in the heading of this be held at FDA White Oak Campus, product. Thereafter, the USPTO document. If you submit a written 10903 New Hampshire Ave., Bldg. 31 requested that FDA determine the petition, two copies are required. A Conference Center, the Great Room (Rm. product’s regulatory review period. petition submitted electronically must 1503), Silver Spring, MD 20993–0002. FDA has determined that the be submitted to http:// Entrance for the public workshop applicable regulatory review period for www.regulations.gov, Docket No. FDA– participants (non-FDA employees) is RAVICTI is 2,126 days. Of this time, 2013–S–0610. Comments and petitions through Building 1 where routine 1,719 days occurred during the testing that have not been made publicly security check procedures will be phase of the regulatory review period, available on http://www.regulations.gov performed. For parking and security while 407 days occurred during the may be viewed in the Division of information, please refer to http:// approval phase. These periods of time Dockets Management between 9 a.m. www.fda.gov/AboutFDA/ were derived from the following dates: and 4 p.m., Monday through Friday. WorkingatFDA/BuildingsandFacilities/ 1. The date an exemption under WhiteOakCampusInformation/ section 505(i) of the Federal Food, Drug, Dated: April 14, 2015. Leslie Kux, ucm241740.htm. and Cosmetic Act (the FD&C Act) (21 Contact Person: Leslie Wheelock, U.S.C. 355(i)) became effective: April Associate Commissioner for Policy. Office of the Commissioner, Food and 10, 2007. The applicant claims April 8, [FR Doc. 2015–08845 Filed 4–16–15; 8:45 am] Drug Administration, 10903 New 2006, as the date the investigational new BILLING CODE 4164–01–P Hampshire Ave., Bldg. 1, Rm. 4345, drug application (IND) became effective. Silver Spring, MD, 301–796–4580, FAX: However, FDA records indicate that the 301–847–8106, leslie.wheelock@ IND effective date was April 10, 2007, DEPARTMENT OF HEALTH AND fda.hhs.gov. when the IND was removed from HUMAN SERVICES Registration: Submit your online clinical hold. 2. The date the application was Food and Drug Administration registration information (including initially submitted with respect to the name, title, firm name, address, [Docket No. FDA–2015–N–0001] telephone and fax numbers) by April 30, human drug product under section 505(b) of the FD&C Act: December 23, 2015, at: http:// Addressing Inadequate Information on www.pharmacy.umaryland.edu/centers/ 2011. FDA has verified the applicant’s Important Health Factors in claim that the new drug application cersievents/biasinbigdata/. There is no Pharmacoepidemiology Studies registration fee for University of (NDA) for RAVICTI (NDA 203284) was Relying on Healthcare Databases; submitted on December 23, 2011. Maryland faculty, students, and staff, Public Workshop University of Maryland Center for 3. The date the application was approved: February 1, 2013. FDA has AGENCY: Food and Drug Administration, Excellence in Regulatory Science and verified the applicant’s claim that NDA HHS. Innovation Industrial Consortia 203284 was approved on February 1, Members, and Federal Government ACTION: Notice of public workshop. 2013. employees. There is a $50.00 This determination of the regulatory The Food and Drug Administration registration fee for all other participants. review period establishes the maximum (FDA) is announcing a public workshop, Early registration is recommended potential length of a patent extension. cosponsored by FDA and the University because seating is limited. There will be However, the USPTO applies several of Maryland Center for Excellence in no onsite registration. statutory limitations in its calculations Regulatory Science and Innovation, If you need special accommodations of the actual period for patent extension. entitled ‘‘Methodological due to a disability, please contact Leslie In its application for patent extension, Considerations to Address Unmeasured Wheelock (see Contact Person) at least this applicant seeks 1,450 days of patent Information About Important Health 7 days in advance. term extension. Factors in Pharmacoepidemiology SUPPLEMENTARY INFORMATION: Anyone with knowledge that any of Studies that Rely on Electronic In many instances, these resources the dates as published are incorrect may Healthcare Databases to Evaluate the allow for the timely evaluation of drug- submit to the Division of Dockets Safety of Regulated Pharmaceutical related adverse events since data on tkelley on DSK3SPTVN1PROD with NOTICES Management (see ADDRESSES) either Products in the Postapproval Setting.’’ healthcare utilized by a large number of electronic or written comments and ask The purpose of the public workshop is individuals are readily available. for a redetermination by June 16, 2015. to engage in constructive dialogue However, because these data are Furthermore, any interested person may among regulators, academicians, typically collected for administrative petition FDA for a determination pharmaceutical industry, clinicians, purposes, information on important regarding whether the applicant for other stakeholders and the general health factors necessary to evaluate extension acted with due diligence public on potential strategies to improve drug-outcome relationship may be VerDate Sep<11>2014 19:08 Apr 16, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1

Federal Register / Vol. 80, No. 74 / Friday, April 17, 2015 / Notices 21249 absent or incomplete in these data Place: National Institutes of Health, The meeting will be open to the sources. Examples include tobacco/ Neuroscience Center, 6001 Executive public as indicated below, with smoking use and history, alcohol Boulevard, Rockville, MD 20852. attendance limited to space available. consumption, weight and height, patient Open: May 6, 2015, 8:30 a.m. to 2:00 p.m. Individuals who plan to attend and Agenda: This portion of the meeting will and family medical history, or use of be open to the public for announcements and need special assistance, such as sign over-the-counter medications. reports of administrative, legislative, and language interpretation or other Incomplete capture or the absence of program developments in the drug abuse reasonable accommodations, should this information can result in biased or field. notify the Contact Person listed below uncertain estimates for the drug- Place: National Institutes of Health, in advance of the meeting. outcome relationship of interest leading Neuroscience Center, 6001 Executive The meeting will be closed to the to inadequate evaluation of the safety Boulevard, Rockville, MD 20852. Contact Person: Susan R.B. Weiss, Ph.D., public in accordance with the profile of prescription drug products. provisions set forth in sections Webcast: Please be advised that as Director, Division of Extramural Research, Office of the Director, National Institute on 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., soon as possible after a Webcast of the as amended. The grant applications Drug Abuse, NIH, DHHS, 6001 Executive public workshop is available, it will be Boulevard, NSC, Room 5274, MSC 9591, and/or contract proposals and the accessible at: http://www.fda.gov/ Rockville, MD 20892, 301–443–6487, discussions could disclose confidential ScienceResearch/SpecialTopics/ sweiss@nida.nih.gov. trade secrets or commercial property RegulatoryScience/ucm429136.htm. Any member of the public interested in such as patentable material, and Dated: April 13, 2015. presenting oral comments to the committee personal information concerning Leslie Kux, may notify the Contact Person listed on this individuals associated with the grant notice at least 10 days in advance of the Associate Commissioner for Policy. applications and/or contract proposals, meeting. Interested individuals and [FR Doc. 2015–08846 Filed 4–16–15; 8:45 am] representatives of organizations may submit the disclosure of which would BILLING CODE 4164–01–P a letter of intent, a brief description of the constitute a clearly unwarranted organization represented, and a short invasion of personal privacy. description of the oral presentation. Only one Name of Committee: National Advisory DEPARTMENT OF HEALTH AND representative of an organization may be Council for Nursing Research. HUMAN SERVICES allowed to present oral comments and if Date: May 19–20, 2015. accepted by the committee, presentations Open: May 19, 2015, 1:00 p.m. to 5:00 p.m. National Institutes of Health may be limited to five minutes. Both printed Agenda: Discussion of Program Policies and electronic copies are requested for the and Issues. National Institute on Drug Abuse; record. In addition, any interested person Place: National Institutes of Health, Notice of Meeting may file written comments with the Building 31, 31 Center Drive, 6th Floor, C committee by forwarding their statement to Wing, Room 6, Bethesda, MD 20892. Pursuant to section 10(d) of the the Contact Person listed on this notice. The Closed: May 20, 2015, 9:00 a.m. to 1:00 Federal Advisory Committee Act, as statement should include the name, address, p.m. amended (5 U.S.C. App.), notice is telephone number and when applicable, the Agenda: To review and evaluate grant hereby given of a meeting of the business or professional affiliation of the applications. interested person. National Advisory Council on Drug Information is also available on the Place: National Institutes of Health, Abuse. Institute’s/Center’s home page: Building 31, 31 Center Drive, 6th Floor, C The meeting will be open to the www.drugabuse.gov/NACDA/ Wing, Room 6, Bethesda, MD 20892. public as indicated below, with NACDAHome.html where an agenda and any Contact Person: Ann R. Knebel, DNSC, RN, attendance limited to space available. additional information for the meeting will FAAN, Deputy Director, National Institute of Individuals who plan to attend and be posted when available. Nursing Research, National Institutes of need special assistance, such as sign Health, 31 Center Drive, Building 31, Room (Catalogue of Federal Domestic Assistance 5B05, Bethesda, MD 20892, 301–496–8230, language interpretation or other Program Nos.: 93.279, Drug Abuse and knebelar@mail.nih.gov. reasonable accommodations, should Addiction Research Programs, National notify the Contact Person listed below Institutes of Health, HHS) Any interested person may file written comments with the committee by forwarding in advance of the meeting. Dated: April 13, 2015. the statement to the Contact Person listed on The meeting will be closed to the Carolyn Baum, this notice. The statement should include the public in accordance with the Program Analyst, Office of Federal Advisory name, address, telephone number and when provisions set forth in sections Committee Policy. applicable, the business or professional 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., [FR Doc. 2015–08800 Filed 4–16–15; 8:45 am] affiliation of the interested person. as amended. The grant applications In the interest of security, NIH has BILLING CODE 4140–01–P and/or contract proposals and the instituted stringent procedures for entrance discussions could disclose confidential onto the NIH campus. All visitor vehicles, trade secrets or commercial property including taxicabs, hotel, and airport shuttles DEPARTMENT OF HEALTH AND will be inspected before being allowed on such as patentable material, and HUMAN SERVICES personal information concerning campus. Visitors will be asked to show one form of identification (for example, a individuals associated with the grant National Institutes of Health government-issued photo ID, driver’s license, applications and/or contract proposals, or passport) and to state the purpose of their the disclosure of which would National Institute of Nursing Research; visit. constitute a clearly unwarranted Notice of Meeting Information is also available on the tkelley on DSK3SPTVN1PROD with NOTICES invasion of personal privacy. Institute’s/Center’s home page: www.nih.gov/ Pursuant to section 10(d) of the ninr/a_advisory.html, where an agenda and Name of Committee: National Advisory Council on Drug Abuse. Federal Advisory Committee Act, as any additional information for the meeting Date: May 5–6, 2015. amended (5 U.S.C. App.), notice is will be posted when available. Closed: May 5, 2015, 1:00 p.m. to 3:00 p.m. hereby given of a meeting of the (Catalogue of Federal Domestic Assistance Agenda: To review and evaluate grant National Advisory Council for Nursing Program Nos. 93.361, Nursing Research, applications and/or proposals. Research. National Institutes of Health, HHS) VerDate Sep<11>2014 19:08 Apr 16, 2015 Jkt 235001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1


Document Created: 2015-12-18 11:20:11
Document Modified: 2015-12-18 11:20:11
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 of public workshop.
FR Citation80 FR 21248 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR