Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop; Correction, 23803 [2015-09966]

Download as PDF Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. III. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in part 25 have been approved under OMB control number 0910–0322 and the collections of information in part 314 have been approved under OMB control number 0910–0001. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. 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, leslie.wheelock@fda.hhs.gov. 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 Dated: April 23, 2015. Peter Lurie, Associate Commissioner for Public Health Strategy and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–09869 Filed 4–28–15; 8:45 am] Food and Drug Administration BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0280] DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators Food and Drug Administration [Docket No. FDA–2015–N–0001] AGENCY: Addressing Inadequate Information on Important Health Factors in Pharmacoepidemiology Studies Relying on Healthcare Databases; Public Workshop; Correction HHS. mstockstill on DSK4VPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. 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 SUMMARY: VerDate Sep<11>2014 17:18 Apr 28, 2015 Jkt 235001 ACTION: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 23803 notice. This notice solicits comments on information collection on financial disclosure by clinical investigators. DATES: Submit either electronic or written comments on the collection of information by June 29, 2015. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Page 23803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
leslie.wheelock@fda.hhs.gov.

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

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