Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections, 53134 [2014-21267]
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53134
Federal Register / Vol. 79, No. 173 / Monday, September 8, 2014 / Rules and Regulations
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 an incorrect RIN
number. This document corrects the
error.
SUMMARY:
DATES:
Effective date: September 8,
2014.
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
correction is made:
1. On page 33073, in the third
column, the RIN number heading is
corrected to read ‘‘RIN 0910–AF96’’.
FOR FURTHER INFORMATION CONTACT:
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
New Animal Drugs; Buprenorphine;
Carprofen; Danofloxacin; Follicle
Stimulating Hormone; Ractopamine;
Salinomycin; Tylosin
21 CFR Part 310, 314, 329, and 600
[Docket No. FDA–2008–N–0334]
AGENCY:
Food and Drug Administration,
HHS.
RIN 0910–AF96
rmajette on DSK2TPTVN1PROD with RULES
BILLING CODE 4164–01–P
[Docket No. FDA–2014–N–0002]
Food and Drug Administration
Final rule; technical
amendment.
ACTION:
Postmarketing Safety Reports for
Human Drug and Biological Products;
Electronic Submission Requirements;
Corrections
Food and Drug Administration,
HHS.
Final rule; corrections.
15:13 Sep 05, 2014
[FR Doc. 2014–21267 Filed 9–5–14; 8:45 am]
21 CFR Parts 520, 522, and 558
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Mar<15>2010
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
BILLING CODE 4164–01–P
ACTION:
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 August 14, 2014, in
FR Doc. 2014–19255, the following
correction is made:
1. On page 47655, in the first column,
add the heading ‘‘RIN 0910–AF96’’
between the Docket No. and the title of
the document.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–21266 Filed 9–5–14; 8:45 am]
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
document entitled ‘‘Postmarketing
Safety Reports for Human Drug and
Biological Products; Electronic
Submission Requirements; Correction’’
that appeared in the Federal Register of
August 14, 2014 (79 FR 47655). The
document published without the
required RIN number and in the Notice
category. This document corrects those
errors.
DATES: Effective Date: September 8,
2014.
SUMMARY:
Jkt 232001
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval actions for new animal drug
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during July 2014. FDA is
SUMMARY:
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to add a cross reference to a
tolerance.
This rule is effective September
8, 2014.
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during July 2014, as listed in
table 1. In addition, FDA is informing
the public of the availability, where
applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain these
documents at the Center for Veterinary
Medicine (CVM) FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
SUPPLEMENTARY INFORMATION:
Also, the animal drug regulations are
being amended in 21 CFR 522.955 to
add a cross reference to a tolerance for
an inactive vehicle in an injectable
dosage form product. This amendment
is being made to improve the accuracy
of the regulations.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
E:\FR\FM\08SER1.SGM
08SER1
]]>Agencies
[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Rules and Regulations]
[Page 53134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 310, 314, 329, and 600
[Docket No. FDA-2008-N-0334]
RIN 0910-AF96
Postmarketing Safety Reports for Human Drug and Biological
Products; Electronic Submission Requirements; Corrections
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; corrections.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
document entitled ``Postmarketing Safety Reports for Human Drug and
Biological Products; Electronic Submission Requirements; Correction''
that appeared in the Federal Register of August 14, 2014 (79 FR 47655).
The document published without the required RIN number and in the
Notice category. This document corrects those errors.
DATES: Effective Date: September 8, 2014.
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 August 14, 2014,
in FR Doc. 2014-19255, the following correction is made:
1. On page 47655, in the first column, add the heading ``RIN 0910-
AF96'' between the Docket No. and the title of the document.
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21267 Filed 9-5-14; 8:45 am]
BILLING CODE 4164-01-P
