Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction, 47655 [2014-19255]

Download as PDF Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices trial designs that may provide evidence of efficacy to support drug approval. The Agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Transcripts will also be available on the Internet at http:// www.fda.gov/Drugs/NewsEvents/ ucm132703.htm approximately 45 days after the workshop. Dated: August 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–19257 Filed 8–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0334] Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a final rule entitled ‘‘Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements’’ that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA’s postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with incorrect information regarding the availability of the International Conference on Harmonization’s (ICH) data elements for tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:42 Aug 13, 2014 Jkt 232001 postmarketing safety reports. The document also published with an incorrect statement regarding the impact of the final rule on small entities. This document corrects those errors. FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4466, Silver Spring, MD 20993–0002, 301–796–1874; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: In the Federal Register of June 10, 2014, in FR Doc. 2014–13480, the following corrections are made: 1. On page 33074, in the first column, under ‘‘Introduction’’, footnote 6 is corrected to read: ‘‘ICH data elements for postmarketing safety reports are provided in the guidance for industry entitled ‘E2B Electronic Transmission of Individual Case Safety Reports Implementation Guide—Data Elements and Message Specification,’ available at http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm.’’ 2. On page 33084, in the second column, under ‘‘Analysis of Impacts’’, the first full sentence is corrected to read: ‘‘Because the average small entity submits few safety reports and the Agency’s Web-based system for submitting reports electronically will require little additional cost per report, the Agency certifies that this final rule will not have a significant economic impact on a substantial number of small entities.’’ Dated: August 8, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–19255 Filed 8–13–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 47655 In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than September 15, 2014. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Federal Tort Claims Act (FTCA) Free Clinic Application OMB No. 0915– 0293—Revision. Abstract: Under 42 U.S.C. 233(o) and Program Assistance Letter (PAL) 2014– 04, ‘‘Calendar Year 2015 Federal Tort Claims Act (FTCA) Deeming Application for Free Clinics,’’ free clinics are required to submit annual applications for deeming of qualified health care professionals, board members, officers, and contractors for purposes of FTCA medical malpractice coverage for negligent acts and omissions that arise from the performance of medical, surgical, dental, or related functions within the scope of the covered individual’s deemed employment. HRSA proposes modifying the application forms to reflect changes to eligible personnel made by section 10608 of the Affordable Care Act, which extended FTCA medical malpractice liability protection to free clinic board members, officers, employees, and contractors. Additionally, HRSA proposes upgrading the application to provide for electronic submissions. Specifically, the modifications include: (1) Inclusion of board members, officers, employees, and contractors into one comprehensive application that also includes volunteer health care professionals and (2) a fully electronic application that can be submitted via HRSA’s web-based application system, the Electronic Handbooks (EHBs). It is anticipated that SUMMARY: E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Page 47655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0334]


Postmarketing Safety Reports for Human Drug and Biological 
Products; Electronic Submission Requirements; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule entitled ``Postmarketing Safety Reports for Human Drug and 
Biological Products; Electronic Submission Requirements'' that appeared 
in the Federal Register of June 10, 2014 (79 FR 33072). The document 
amended FDA's postmarketing safety reporting regulations for human drug 
and biological products to require that persons subject to mandatory 
reporting requirements submit safety reports in an electronic format 
that FDA can process, review, and archive. The document was published 
with incorrect information regarding the availability of the 
International Conference on Harmonization's (ICH) data elements for 
postmarketing safety reports. The document also published with an 
incorrect statement regarding the impact of the final rule on small 
entities. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 4466, Silver Spring, MD 20993-0002, 301-796-1874; or 
Stephen Ripley, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:  In the Federal Register of June 10, 2014, 
in FR Doc. 2014-13480, the following corrections are made:
    1. On page 33074, in the first column, under ``Introduction'', 
footnote 6 is corrected to read: ``ICH data elements for postmarketing 
safety reports are provided in the guidance for industry entitled `E2B 
Electronic Transmission of Individual Case Safety Reports 
Implementation Guide--Data Elements and Message Specification,' 
available at http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
    2. On page 33084, in the second column, under ``Analysis of 
Impacts'', the first full sentence is corrected to read: ``Because the 
average small entity submits few safety reports and the Agency's Web-
based system for submitting reports electronically will require little 
additional cost per report, the Agency certifies that this final rule 
will not have a significant economic impact on a substantial number of 
small entities.''

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19255 Filed 8-13-14; 8:45 am]
BILLING CODE 4164-01-P