80 FR 23803 - Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

Page Range		23803-23803
FR Document		2015-09966

The Food and Drug Administration is correcting a notice entitled ``Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop'' that appeared in the Federal Register of April 17, 2015 (80 FR 21248). The document announced a public workshop. The document was published with the incorrect title. This document corrects that error.

Federal Register, Volume 80 Issue 82 (Wednesday, April 29, 2015)

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Page 23803]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09966]


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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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Addressing Inadequate Information on Important Health 
Factors in Pharmacoepidemiology Studies Relying on Healthcare 
Databases; Public Workshop'' that appeared in the Federal Register of 
April 17, 2015 (80 FR 21248). The document announced a public workshop. 
The document was published with the incorrect title. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Leslie Wheelock, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 4345, Silver Spring, MD, 301-796-8450, FAX: 301-847-8106, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of April 17, 2015, 
in FR Doc. 2015-08846, on page 21248 the following correction(s) is/are 
made:
    1. On page 21248, in the second column, starting at the sixth 
sentence of the first paragraph, the title ``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'' is corrected to read 
``Inadequate Information on Important Health Factors in 
Pharmacoepidemiology Studies Relying on Healthcare Databases.''

    Dated: April 23, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09966 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices 23803

II. Comments Workshop’’ that appeared in the Federal notice. This notice solicits comments on
Interested persons may submit either Register of April 17, 2015 (80 FR information collection on financial
electronic comments regarding this 21248). The document announced a disclosure by clinical investigators.
document to http://www.regulations.gov public workshop. The document was DATES: Submit either electronic or
or written comments to the Division of published with the incorrect title. This written comments on the collection of
Dockets Management (see ADDRESSES). It document corrects that error. information by June 29, 2015.
is only necessary to send one set of FOR FURTHER INFORMATION CONTACT: ADDRESSES: Submit electronic
comments. Identify comments with the Leslie Wheelock, Office of the comments on the collection of
docket number found in brackets in the Commissioner, Food and Drug information to http://
heading of this document. Received Administration, 10903 New Hampshire www.regulations.gov. Submit written
comments may be seen in the Division Ave., Bldg. 1, Rm. 4345, Silver Spring, comments on the collection of
of Dockets Management between 9 a.m. MD, 301–796–8450, FAX: 301–847– information to the Division of Dockets
and 4 p.m., Monday through Friday, and 8106, leslie.wheelock@fda.hhs.gov. Management (HFA–305), Food and Drug
will be posted to the docket at http:// SUPPLEMENTARY INFORMATION: In the Administration, 5630 Fishers Lane, rm.
www.regulations.gov. Federal Register of April 17, 2015, in 1061, Rockville, MD 20852. All
FR Doc. 2015–08846, on page 21248 the comments should be identified with the
III. The Paperwork Reduction Act of following correction(s) is/are made: docket number found in brackets in the
1995 1. On page 21248, in the second heading of this document.
This draft guidance refers to column, starting at the sixth sentence of FOR FURTHER INFORMATION CONTACT: FDA
previously approved collections of the first paragraph, the title PRA Staff, Office of Operations, Food
information that are subject to review by ‘‘Methodological Considerations to and Drug Administration, 8455
the Office of Management and Budget Address Unmeasured Information Colesville Rd., COLE–14526, Silver
(OMB) under the Paperwork Reduction About Important Health Factors in Spring, MD 20993–0002, PRAStaff@
Act of 1995 (44 U.S.C. 3501–3520). The Pharmacoepidemiology Studies that fda.hhs.gov.
collections of information in part 25 Rely on Electronic Healthcare Databases SUPPLEMENTARY INFORMATION: Under the
have been approved under OMB control to Evaluate the Safety of Regulated PRA (44 U.S.C. 3501–3520), Federal
number 0910–0322 and the collections Pharmaceutical Products in the Agencies must obtain approval from the
of information in part 314 have been Postapproval Setting’’ is corrected to Office of Management and Budget
approved under OMB control number read ‘‘Inadequate Information on (OMB) for each collection of
0910–0001. Important Health Factors in information they conduct or sponsor.
Pharmacoepidemiology Studies Relying ‘‘Collection of information’’ is defined
IV. Electronic Access
on Healthcare Databases.’’ in 44 U.S.C. 3502(3) and 5 CFR
Persons with access to the Internet Dated: April 23, 2015. 1320.3(c) and includes Agency requests
may obtain the document at either or requirements that members of the
Peter Lurie,
http://www.fda.gov/Drugs/Guidance public submit reports, keep records, or
Associate Commissioner for Public Health
ComplianceRegulatoryInformation/ provide information to a third party.
Strategy and Analysis.
Guidances/default.htm or http:// Section 3506(c)(2)(A) of the PRA (44
[FR Doc. 2015–09966 Filed 4–28–15; 8:45 am]
www.regulations.gov. U.S.C. 3506(c)(2)(A)) requires Federal
BILLING CODE 4164–01–P
Dated: April 23, 2015. Agencies to provide a 60-day notice in
Peter Lurie, the Federal Register concerning each
Associate Commissioner for Public Health DEPARTMENT OF HEALTH AND proposed collection of information,
Strategy and Analysis. HUMAN SERVICES including each proposed extension of an
[FR Doc. 2015–09869 Filed 4–28–15; 8:45 am]
existing collection of information,
Food and Drug Administration before submitting the collection to OMB
BILLING CODE 4164–01–P
for approval. To comply with this
[Docket No. FDA–2012–N–0280] requirement, FDA is publishing notice
DEPARTMENT OF HEALTH AND of the proposed collection of
Agency Information Collection
HUMAN SERVICES information set forth in this document.
Activities; Proposed Collection; With respect to the following
Comment Request; Financial collection of information, FDA invites
Food and Drug Administration Disclosure by Clinical Investigators comments on these topics: (1) Whether
[Docket No. FDA–2015–N–0001] the proposed collection of information
AGENCY: Food and Drug Administration,
HHS. is necessary for the proper performance
Addressing Inadequate Information on
ACTION: Notice. of FDA’s functions, including whether
Important Health Factors in
the information will have practical
Pharmacoepidemiology Studies
SUMMARY: The Food and Drug utility; (2) the accuracy of FDA’s
Relying on Healthcare Databases;
Administration (FDA) is announcing an estimate of the burden of the proposed
Public Workshop; Correction
opportunity for public comment on the collection of information, including the
AGENCY: Food and Drug Administration, proposed collection of certain validity of the methodology and
HHS. information by the Agency. Under the assumptions used; (3) ways to enhance
mstockstill on DSK4VPTVN1PROD with NOTICES

ACTION: Notice; correction. Paperwork Reduction Act of 1995 (the the quality, utility, and clarity of the
PRA), Federal Agencies are required to information to be collected; and (4)
SUMMARY: The Food and Drug publish notice in the Federal Register ways to minimize the burden of the
Administration is correcting a notice concerning each proposed collection of collection of information on
entitled ‘‘Addressing Inadequate information, including each proposed respondents, including through the use
Information on Important Health Factors extension of an existing collection of of automated collection techniques,
in Pharmacoepidemiology Studies information, and to allow 60 days for when appropriate, and other forms of
Relying on Healthcare Databases; Public public comment in response to the information technology.

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Document Created: 2015-12-16 08:25:51
Document Modified: 2015-12-16 08:25:51

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; correction.
Contact		Leslie Wheelock, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4345, Silver Spring, MD, 301-796-8450, FAX: 301-847-8106, [email protected]
FR Citation		80 FR 23803

80 FR 23803 - Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration