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