Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration, 33756-33757 [2014-13788]
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Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
for these studies and to provide an
adequate degree of consumer protection,
the Agency issued GLP regulations for
nonclinical laboratory studies in part 58
(21 CFR part 58). The regulations
specify minimum standards for the
proper conduct of safety testing and
contain sections on facilities, personnel,
equipment, standard operating
procedures (SOPs), test and control
articles, quality assurance, protocol and
conduct of a safety study, records and
reports, and laboratory disqualification.
Part 58 requires testing facilities
engaged in conducting toxicological
studies to retain, and make available to
regulatory officials, records regarding
compliance with good laboratory
practices. Records are maintained on
file at each testing facility and examined
there periodically by FDA inspectors.
The GLP regulations require that, for
each nonclinical laboratory study, a
final report be prepared that documents
the results of quality assurance unit
inspections, test and control article
characterization, testing of mixtures of
test and control articles with carriers,
and an overall interpretation of
nonclinical laboratory studies. The GLP
regulations also require written records
pertaining to: (1) Personnel job
descriptions and summaries of training
and experience; (2) master schedules,
protocols and amendments thereto,
inspection reports, and SOPs; (3)
equipment inspection, maintenance,
calibration, and testing records; (4)
documentation of feed and water
analyses, and animal treatments; (5) test
article accountability records; and (6)
study documentation and raw data.
Recordkeeping is necessary to
document the conduct of nonclinical
laboratory studies of FDA-regulated
products to ensure the quality and
integrity of the resulting final study
report on which a regulatory decision
may be based. Written SOPs and records
of actions taken are essential for testing
facilities to implement GLP’s effectively.
Further, they are essential for FDA to be
able to determine a testing facility’s
compliance with the GLP regulations in
part 58.
Description of Respondents: The
likely respondents collecting this
information are contract laboratories,
sponsors of FDA-regulated products,
universities, or government agencies.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average burden
per
recordkeeping
Total annual
records
Total hours
58.29(b); Personnel ....................................................
58.35(b)(1)–(b)(6) and (c); Quality assurance ...........
58.35(b)(7); Quality assurance ...................................
58.63(b) and (c); Maintenance and calibration of
equipment.
58.81(a)–(c); SOPs ....................................................
58.90(c) and (g); Animal care ....................................
58.105(a) and (b); Test and control article characterization.
58.107(d); Test and control article handling ..............
58.113(a); Mixtures of articles with carriers ...............
58.120; Protocol .........................................................
58.185; Nonclinical laboratory study results ..............
58.195; Retention of records ......................................
300
300
300
300
20
270.76
60.25
60
6,000
81,228
18,075
18,000
0.21 (13 minutes)
3.36
1
0.09 (5 minutes)
1,260
279,926
18,075
1,620
300
300
300
301.8
62.7
5
90,540
18,810
1,500
0.14 (8 minutes)
0.13(8 minutes)
11.8
12,676
2,445
17,700
300
300
300
300
300
1
15.33
15.38
60.25
251.5
300
4,599
4,614
18,075
75,450
4.25
6.8
32.7
27.65
3.9
Total ....................................................................
........................
..........................
........................
1 There
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fax or email written comments
on the collection of information by July
14, 2014.
DATES:
Food and Drug Administration
[Docket No. FDA–2013–D–0984]
Food and Drug Administration,
VerDate Mar<15>2010
21:18 Jun 11, 2014
Jkt 232001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0045. Also
include the FDA docket number found
ADDRESSES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Specification of the Unique
Facility Identifier System for Drug
Establishment Registration
HHS.
in brackets in the heading of this
document.
Notice.
SUMMARY:
[FR Doc. 2014–13787 Filed 6–11–14; 8:45 am]
rmajette on DSK7SPTVN1PROD with NOTICES
1,311,157
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1,275
31,273
150,878
499,774
294,255
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution (OMB Control Number
0910–0045)
In the Federal Register of September
6, 2013 (78 FR 54899), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Specification of the
Unique Facility Identifier (UFI) System
E:\FR\FM\12JNN1.SGM
12JNN1
rmajette on DSK7SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 113 / Thursday, June 12, 2014 / Notices
for Drug Establishment Registration.’’
Sections 701 and 702 of the Food and
Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144) direct the Secretary to specify the
UFI system for registration of domestic
and foreign drug establishments. Once
the UFI system is specified, section 510
of the Federal, Food, Drug, and
Cosmetic Act (FD&C Act), as amended,
requires that each initial and annual
drug establishment registration include
a UFI (21 U.S.C. 360(b), (c), and (i)).
This draft guidance specifies the UFI
system as follows. At this time, FDA’s
preferred UFI for a drug establishment
is the Data Universal Numbering System
D–U–N–S (DUNS) number, assigned
and managed by Dun and Bradstreet.
The DUNS number is available free of
charge to all drug establishments and
may be obtained by visiting the Web site
for Dun and Bradstreet. As explained in
the guidance, however, if a company
wants to use an alternative UFI for its
drug establishment, it may contact FDA
via email at edrls@fda.hhs.gov.
OMB has previously approved
existing information collections
associated with the electronic
submission of initial and annual
registration of domestic and foreign
drug establishments, as described in
part 207 (21 CFR part 207) and the
guidance document ‘‘Providing
Regulatory Submissions in Electronic
Format—Drug Establishment
Registration and Drug Listing’’ (the 2009
Guidance) (available at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM072339.pdf), under OMB control
number 0910–0045. The Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85) required that drug
establishment registration and drug
listing information must be submitted
electronically unless a waiver is
granted. As part of its recommendations
to facilitate electronic submission of
drug establishment registration
information, as required by statute, the
2009 guidance explained that FDA is
adopting the use of extensible markup
language files in a standard structured
product labeling format for the
electronic submission of drug
establishment registration and drug
listing information. The 2009 guidance
also explained that the automated
submission process functions most
efficiently and effectively when the
information is provided in a
standardized format with defined code
sets and codes. In addition, the 2009
guidance requested, among other things,
the electronic submission of a site-
VerDate Mar<15>2010
21:18 Jun 11, 2014
Jkt 232001
specific DUNS number for each entity as
part of the registration information
submitted electronically. In FDA’s
experience, all firms currently registered
with FDA under section 510 of the
FD&C Act and part 207 have submitted
their DUNS number as requested in the
2009 guidance.
The guidance modifies the currently
approved information collections
associated with drug establishment
registration, consistent with subsequent
statutory enactment. In July 2012,
Congress enacted FDASIA, sections 701
and 702 of which direct the Secretary to
specify the UFI system for registration of
domestic and foreign drug
establishments. Once the UFI system is
specified, section 510 of the FD&C Act,
as amended, requires that each initial
and annual drug establishment
registration include a UFI. Because drug
firms generally possess, and for those
already registered, have previously
provided, a DUNS number for each
facility, FDA expects that consistent
with the proposed UFI system, they will
submit DUNS numbers as the UFIs for
drug establishments. Although the
change in statutory authority described
in this document will alter the legal
basis for submission of the DUNS
number, it is not expected to have any
other impact on the previously
approved collection of information.
FDA expects that the DUNS number
will continue to be submitted by the
same respondents, with the same
frequency, as part of the same electronic
registration submission previously
approved under the PRA, and the
Agency will continue to use the
information for the same purposes, in
furtherance of its mission to protect the
public health.
While FDA anticipates that firms will
submit DUNS as UFI, the guidance also
suggests that firms who want to submit
an alternative identifier contact FDA.
FDA estimates that no more than one
respondent per year will invoke this
option. FDA estimates that it would
require on average 1 hour for a company
to contact FDA and identify its
proposed alternative UFI.
In the Federal Register of September
6, 2013 (78 FR 54899), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received three
comments that did not pertain to the
information collection. Upon review of
these comments FDA does not plan to
revise the information collection.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
33757
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13788 Filed 6–11–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2006–P–0136 (Formerly
Docket No. 2006P–0496) and Docket No.
FDA–2007–P–0353 (Formerly Docket No.
2007P–0034)]
Determination That AZO GANTANOL
(Phenazopyridine Hydrochloride,
Sulfamethoxazole) Tablet, 100
Milligrams/500 Milligrams, and AZO
GANTRISIN (Phenazopyridine
Hydrochloride, Sulfisoxazole) Tablet,
50 Milligrams/500 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing its
determination that AZO GANTANOL
(phenazopyridine hydrochloride (HCl)
and sulfamethoxazole) Tablet, 100
milligrams (mg)/500 mg, and AZO
GANTRISIN (phenazopyridine HCl and
sulfisoxazole) Tablet, 50 mg/500 mg,
were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
phenazopyridine HCl and
sulfamethoxazole tablet, 100 mg/500
mg, and phenazopyridine HCl and
sulfisoxazole tablet, 50 mg/500 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6254, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
SUMMARY:
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33756-33757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0984]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Specification of the Unique Facility Identifier System for Drug
Establishment Registration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax or email written comments on the collection of information
by July 14, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0045.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution (OMB Control Number 0910-0045)
In the Federal Register of September 6, 2013 (78 FR 54899), FDA
announced the availability of a draft guidance for industry entitled
``Specification of the Unique Facility Identifier (UFI) System
[[Page 33757]]
for Drug Establishment Registration.'' Sections 701 and 702 of the Food
and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L.
112-144) direct the Secretary to specify the UFI system for
registration of domestic and foreign drug establishments. Once the UFI
system is specified, section 510 of the Federal, Food, Drug, and
Cosmetic Act (FD&C Act), as amended, requires that each initial and
annual drug establishment registration include a UFI (21 U.S.C. 360(b),
(c), and (i)). This draft guidance specifies the UFI system as follows.
At this time, FDA's preferred UFI for a drug establishment is the Data
Universal Numbering System D-U-N-S (DUNS) number, assigned and managed
by Dun and Bradstreet. The DUNS number is available free of charge to
all drug establishments and may be obtained by visiting the Web site
for Dun and Bradstreet. As explained in the guidance, however, if a
company wants to use an alternative UFI for its drug establishment, it
may contact FDA via email at edrls@fda.hhs.gov.
OMB has previously approved existing information collections
associated with the electronic submission of initial and annual
registration of domestic and foreign drug establishments, as described
in part 207 (21 CFR part 207) and the guidance document ``Providing
Regulatory Submissions in Electronic Format--Drug Establishment
Registration and Drug Listing'' (the 2009 Guidance) (available at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf), under
OMB control number 0910-0045. The Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110-85) required that drug
establishment registration and drug listing information must be
submitted electronically unless a waiver is granted. As part of its
recommendations to facilitate electronic submission of drug
establishment registration information, as required by statute, the
2009 guidance explained that FDA is adopting the use of extensible
markup language files in a standard structured product labeling format
for the electronic submission of drug establishment registration and
drug listing information. The 2009 guidance also explained that the
automated submission process functions most efficiently and effectively
when the information is provided in a standardized format with defined
code sets and codes. In addition, the 2009 guidance requested, among
other things, the electronic submission of a site-specific DUNS number
for each entity as part of the registration information submitted
electronically. In FDA's experience, all firms currently registered
with FDA under section 510 of the FD&C Act and part 207 have submitted
their DUNS number as requested in the 2009 guidance.
The guidance modifies the currently approved information
collections associated with drug establishment registration, consistent
with subsequent statutory enactment. In July 2012, Congress enacted
FDASIA, sections 701 and 702 of which direct the Secretary to specify
the UFI system for registration of domestic and foreign drug
establishments. Once the UFI system is specified, section 510 of the
FD&C Act, as amended, requires that each initial and annual drug
establishment registration include a UFI. Because drug firms generally
possess, and for those already registered, have previously provided, a
DUNS number for each facility, FDA expects that consistent with the
proposed UFI system, they will submit DUNS numbers as the UFIs for drug
establishments. Although the change in statutory authority described in
this document will alter the legal basis for submission of the DUNS
number, it is not expected to have any other impact on the previously
approved collection of information. FDA expects that the DUNS number
will continue to be submitted by the same respondents, with the same
frequency, as part of the same electronic registration submission
previously approved under the PRA, and the Agency will continue to use
the information for the same purposes, in furtherance of its mission to
protect the public health.
While FDA anticipates that firms will submit DUNS as UFI, the
guidance also suggests that firms who want to submit an alternative
identifier contact FDA. FDA estimates that no more than one respondent
per year will invoke this option. FDA estimates that it would require
on average 1 hour for a company to contact FDA and identify its
proposed alternative UFI.
In the Federal Register of September 6, 2013 (78 FR 54899), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received three comments that did not
pertain to the information collection. Upon review of these comments
FDA does not plan to revise the information collection.
Dated: June 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13788 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P
