Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance, 69857-69859 [2014-27691]
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Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
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good manufacturing practice for drugs).
This guidance describes in detail the fee
types and amounts an entity must pay
to satisfy the fee requirements of
sections 503B and 744K of the FD&C
Act to be deemed an outsourcing facility
and maintain its status as an
outsourcing facility, the adjustments to
the fees required by law, how to qualify
as a small business to obtain a reduction
of the annual establishment fee, how
and when to submit payment to FDA,
the effect of failure to pay fees, and feerelated dispute resolution.
On April 1, 2014 (79 FR 18297), FDA
announced the availability of the draft
version of this guidance. The public
comment period closed on June 2, 2014.
One comment was received from the
public, and FDA carefully considered
that comment as it finalized the
guidance. Some of the issues raised
relate to matters that FDA intends to
address in other policy documents and
were not directly pertinent to the topics
addressed in this guidance. During
finalization of the guidance, FDA made
both clarifying changes and minor
editorial changes to the guidance and
accompanying form. For example, FDA
clarified that it intends to issue an
invoice for reinspection fees within 14
calendar days of the close of the
reinspection, and that the reinspection
fee must be paid within 30 calendar
days of the date of the invoice.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on fees associated with human
drug compounding outsourcing
facilities. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons can 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 can 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. Paperwork Reduction Act of 1995
This guidance contains collections of
information that are subject to review by
VerDate Sep<11>2014
20:32 Nov 21, 2014
Jkt 235001
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3520). The
collections of information have been
approved under OMB control number
0910–0776.
IV. Electronic Access
Persons with access to the Internet
can obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27692 Filed 11–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1428]
Electronic Product Reporting for
Human Drug Compounding
Outsourcing Facilities; Draft Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a revised
draft guidance entitled ‘‘Electronic
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ The
revised draft guidance addresses
provisions in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) added
by the Drug Quality and Security Act
(DQSA) and updates reporting
instructions for drug compounders that
choose to register as outsourcing
facilities. Such compounders must
report information on the drugs they
have compounded in Structured
Product Labeling (SPL) format using
FDA’s electronic submissions system.
This revised draft guidance supersedes
a draft guidance entitled ‘‘Interim
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comments on this
revised draft guidance, submit either
electronic or written comments on the
revised draft guidance by January 23,
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
69857
2015. Submit either electronic or
written comments concerning the
collection of information proposed in
the revised draft guidance by January
23, 2015.
ADDRESSES: Submit written requests for
single copies of the revised draft
guidance document to the Division of
Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the revised draft guidance.
Submit electronic comments on the
revised draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lysette Deshields, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Electronic Product Reporting
for Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.’’ In the Federal Register
of December 4, 2013 (78 FR 72897), FDA
issued a notice announcing the
availability of an initial draft of this
guidance entitled ‘‘Interim Product
Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ That
draft guidance addressed new
provisions in the FD&C Act added by
the DQSA and set forth an interim
submission method for human drug
compounders that choose to register as
outsourcing facilities.
The comment period on the initial
draft guidance ended on February 3,
2014. FDA received six comments on
the draft. In response to received
comments or on its own initiative, FDA
made the following changes and
updates in the revised draft guidance:
(1) Modified the scope of the guidance
to refer to product reports submitted in
SPL format; (2) clarified the following
elements required in a product report:
‘‘Strength of the active ingredient per
unit,’’ ‘‘package description,’’ and
E:\FR\FM\24NON1.SGM
24NON1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
69858
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
‘‘number of individual units produced’’;
(3) included language that discusses the
time period during which outsourcing
facilities must submit product reports;
(4) included the appropriate SPL
document type category for outsourcing
facilities submitting a product report
and a reference to detailed instructions
on how to submit information using
SPL; (5) clarified that reports submitted
under section 503B(b)(2) of the FD&C
Act (21 U.S.C. 353b(b)(2)) are exempt
from inspection unless the Secretary
finds that such an exemption would be
inconsistent with the protection of the
public health; and (6) made grammatical
and other minor editorial changes for
clarity.
In some cases, received comments
raised issues that were not directly
pertinent to the topics addressed in the
draft. This revised draft guidance
explains that registered outsourcing
facilities must provide reports to FDA
on compounded drugs in SPL format
using FDA’s electronic submissions
system. It supersedes the draft guidance
entitled ‘‘Interim Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Section 503B(b)(2)(B) of the FD&C Act
provides that a facility that elects to
register with FDA as an outsourcing
facility is required to report to FDA
information about the drugs
compounded at that outsourcing facility
in the form and manner as FDA may
‘‘prescribe by regulation or guidance.’’
Congress gave FDA explicit statutory
authority to establish binding
requirements on this topic in guidance.
Therefore, this guidance is not subject to
the usual restrictions in FDA’s good
guidance practice regulations (e.g., the
requirements that guidances not
establish legally enforceable
responsibilities and that guidances
prominently display a statement of the
document’s nonbinding effect); see 21
CFR 10.115(d)(1)).
As provided in section 503B of the
DQSA, this revised draft guidance
explains the form and manner in which
registered outsourcing facilities are
required to submit drug reporting
information. This revised draft
guidance, when finalized, will prescribe
the form and manner for submitting
drug product reports to FDA under
section 503B of the FD&C Act and will
have binding effect under section
503B(b)(2)(B). Until this draft guidance
is finalized, FDA will accept drug
product reports submitted in accordance
with the form and manner described in
FDA’s initial draft guidance on this
subject. However, FDA strongly
encourages outsourcing facilities to
VerDate Sep<11>2014
20:32 Nov 21, 2014
Jkt 235001
submit drug product reports as
described in this revised draft guidance.
Elsewhere in this issue of the Federal
Register, FDA is making available a
final guidance on registration for human
drug compounding outsourcing
facilities under section 503B of the
FD&C Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (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 that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this
document, FDA invites comments on
the following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the revised draft guidance,
registered outsourcing facilities must
submit to FDA a report identifying all
drugs compounded by the facility
during the previous 6-month period.
The report must be submitted upon
initial registration as an outsourcing
facility, once in June, and once in
December of each year. The report must
include the following information for all
drugs compounded at the outsourcing
facility during the previous 6-month
period:
• The active ingredient and strength
of active ingredient per unit
• The source of the active ingredient
(bulk or finished)
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
• The National Drug Code (NDC)
number of the source drug or bulk active
ingredient, if available
• The dosage form and route of
administration
• The package description
• The number of individual units
produced
• The NDC number of the final
product, if assigned
Product reports must be submitted to
FDA electronically in SPL format, as
described in the revised draft guidance.
Outsourcing facilities can request a
waiver from the electronic submission
process by submitting a written request
to FDA explaining why the use of
electronic means is not reasonable for
them.
Based on our familiarity with
outsourcing facilities, we estimate that
annually a total of approximately 50
outsourcing facilities (‘‘number of
respondents’’ in table 1, row 1) will
submit to FDA at the time of initial
registration a report identifying all drugs
compounded in the facility. We also
estimate that these outsourcing facilities
will submit a total of approximately 50
reports for compounded drugs
containing the information specified in
the draft guidance (‘‘total annual
responses’’ in table 1, row 1). We
estimate that preparing and submitting
this information electronically will take
approximately 2 hours per report
(‘‘average burden per response’’ in table
1, row 1). We expect to receive no more
than one waiver request from this
electronic submission process (‘‘total
annual responses’’ in table 1, row 2),
and each request should take
approximately 1 hour to prepare and
submit to us (‘‘average burden per
response’’ in table 1, row 2).
We also estimate that a total of
approximately 50 outsourcing facilities
(‘‘number of respondents’’ in table 2,
row 1) will submit to FDA a report twice
each year identifying all drugs
compounded at the facility. We estimate
that these outsourcing facilities will
submit a total of approximately 50
reports in December and 50 reports in
June containing the information
specified in the draft revised guidance
(‘‘total annual responses’’ in table 2, row
1). We estimate that preparing and
submitting this information
electronically will take approximately 2
hours per report (‘‘average burden per
response’’ in table 2, row 1). We expect
to receive no more than one waiver
request from the electronic submission
process (‘‘total annual responses’’ in
table 2, row 2), and each request should
take approximately 1 hour to prepare
and submit to us (‘‘average burden per
response’’ in table 2, row 2).
E:\FR\FM\24NON1.SGM
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69859
Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Product reporting for compounding outsourcing facilities
Average
burden per
response
Total annual
responses
Total hours
Submission of Initial Product Report ...................................
Waiver Request from Electronic Submission of Initial Product Report .........................................................................
50
1
50
2
100
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
101
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Product reporting for compounding outsourcing facilities
Average burden per
response
Total annual
responses
Total hours
Submission of December Product Report ...........................
Submission of June Product Report ....................................
Waiver Request from Electronic Submission of Product
Reports .............................................................................
50
50
1
1
50
50
2
2
100
100
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
201
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons can 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 can be viewed at 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1429]
Registration of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the FD&C Act;
Final Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–27691 Filed 11–21–14; 8:45 am]
asabaliauskas on DSK5VPTVN1PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
20:32 Nov 21, 2014
Jkt 235001
The Food and Drug
Administration (FDA) is announcing the
availability of a final guidance for
industry entitled ‘‘Registration of
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
FD&C Act.’’ The guidance addresses
new provisions in the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the Drug Quality and
Security Act (DQSA). The guidance is
intended to assist human drug
compounders that elect to register as
outsourcing facilities in registering, reregistering, or de-registering with FDA.
The guidance provides information on
how an outsourcing facility should
submit facility registration information
electronically in structured product
labeling (SPL) format using FDA’s
electronic submission system. This
guidance reflects the Agency’s current
thinking on the issues addressed by the
guidance.
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the final guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the final guidance document.
Submit electronic comments on the
final guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Soo
Jin Park, Drug Registration and Listing
Team, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3100.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Registration of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the FD&C Act.’’
This guidance is being issued consistent
with the new authority conferred to
FDA in the DQSA (Pub. L. 113–54). In
that legislation, Congress created a new
category for certain facilities that
E:\FR\FM\24NON1.SGM
24NON1
]]>Agencies
[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69857-69859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27691]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Electronic Product Reporting for Human Drug Compounding
Outsourcing Facilities; Draft Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a revised draft guidance entitled
``Electronic Product Reporting for Human Drug Compounding Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' The revised draft guidance addresses provisions in the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality
and Security Act (DQSA) and updates reporting instructions for drug
compounders that choose to register as outsourcing facilities. Such
compounders must report information on the drugs they have compounded
in Structured Product Labeling (SPL) format using FDA's electronic
submissions system. This revised draft guidance supersedes a draft
guidance entitled ``Interim Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.''
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comments on
this revised draft guidance, submit either electronic or written
comments on the revised draft guidance by January 23, 2015. Submit
either electronic or written comments concerning the collection of
information proposed in the revised draft guidance by January 23, 2015.
ADDRESSES: Submit written requests for single copies of the revised
draft guidance document to the Division of Drug Information, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revised draft guidance.
Submit electronic comments on the revised draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Electronic Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' In the Federal Register of December 4,
2013 (78 FR 72897), FDA issued a notice announcing the availability of
an initial draft of this guidance entitled ``Interim Product Reporting
for Human Drug Compounding Outsourcing Facilities Under Section 503B of
the Federal Food, Drug, and Cosmetic Act.'' That draft guidance
addressed new provisions in the FD&C Act added by the DQSA and set
forth an interim submission method for human drug compounders that
choose to register as outsourcing facilities.
The comment period on the initial draft guidance ended on February
3, 2014. FDA received six comments on the draft. In response to
received comments or on its own initiative, FDA made the following
changes and updates in the revised draft guidance: (1) Modified the
scope of the guidance to refer to product reports submitted in SPL
format; (2) clarified the following elements required in a product
report: ``Strength of the active ingredient per unit,'' ``package
description,'' and
[[Page 69858]]
``number of individual units produced''; (3) included language that
discusses the time period during which outsourcing facilities must
submit product reports; (4) included the appropriate SPL document type
category for outsourcing facilities submitting a product report and a
reference to detailed instructions on how to submit information using
SPL; (5) clarified that reports submitted under section 503B(b)(2) of
the FD&C Act (21 U.S.C. 353b(b)(2)) are exempt from inspection unless
the Secretary finds that such an exemption would be inconsistent with
the protection of the public health; and (6) made grammatical and other
minor editorial changes for clarity.
In some cases, received comments raised issues that were not
directly pertinent to the topics addressed in the draft. This revised
draft guidance explains that registered outsourcing facilities must
provide reports to FDA on compounded drugs in SPL format using FDA's
electronic submissions system. It supersedes the draft guidance
entitled ``Interim Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.''
Section 503B(b)(2)(B) of the FD&C Act provides that a facility that
elects to register with FDA as an outsourcing facility is required to
report to FDA information about the drugs compounded at that
outsourcing facility in the form and manner as FDA may ``prescribe by
regulation or guidance.'' Congress gave FDA explicit statutory
authority to establish binding requirements on this topic in guidance.
Therefore, this guidance is not subject to the usual restrictions in
FDA's good guidance practice regulations (e.g., the requirements that
guidances not establish legally enforceable responsibilities and that
guidances prominently display a statement of the document's nonbinding
effect); see 21 CFR 10.115(d)(1)).
As provided in section 503B of the DQSA, this revised draft
guidance explains the form and manner in which registered outsourcing
facilities are required to submit drug reporting information. This
revised draft guidance, when finalized, will prescribe the form and
manner for submitting drug product reports to FDA under section 503B of
the FD&C Act and will have binding effect under section 503B(b)(2)(B).
Until this draft guidance is finalized, FDA will accept drug product
reports submitted in accordance with the form and manner described in
FDA's initial draft guidance on this subject. However, FDA strongly
encourages outsourcing facilities to submit drug product reports as
described in this revised draft guidance.
Elsewhere in this issue of the Federal Register, FDA is making
available a final guidance on registration for human drug compounding
outsourcing facilities under section 503B of the FD&C Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Under the revised draft guidance, registered outsourcing facilities
must submit to FDA a report identifying all drugs compounded by the
facility during the previous 6-month period. The report must be
submitted upon initial registration as an outsourcing facility, once in
June, and once in December of each year. The report must include the
following information for all drugs compounded at the outsourcing
facility during the previous 6-month period:
The active ingredient and strength of active ingredient
per unit
The source of the active ingredient (bulk or finished)
The National Drug Code (NDC) number of the source drug or
bulk active ingredient, if available
The dosage form and route of administration
The package description
The number of individual units produced
The NDC number of the final product, if assigned
Product reports must be submitted to FDA electronically in SPL
format, as described in the revised draft guidance. Outsourcing
facilities can request a waiver from the electronic submission process
by submitting a written request to FDA explaining why the use of
electronic means is not reasonable for them.
Based on our familiarity with outsourcing facilities, we estimate
that annually a total of approximately 50 outsourcing facilities
(``number of respondents'' in table 1, row 1) will submit to FDA at the
time of initial registration a report identifying all drugs compounded
in the facility. We also estimate that these outsourcing facilities
will submit a total of approximately 50 reports for compounded drugs
containing the information specified in the draft guidance (``total
annual responses'' in table 1, row 1). We estimate that preparing and
submitting this information electronically will take approximately 2
hours per report (``average burden per response'' in table 1, row 1).
We expect to receive no more than one waiver request from this
electronic submission process (``total annual responses'' in table 1,
row 2), and each request should take approximately 1 hour to prepare
and submit to us (``average burden per response'' in table 1, row 2).
We also estimate that a total of approximately 50 outsourcing
facilities (``number of respondents'' in table 2, row 1) will submit to
FDA a report twice each year identifying all drugs compounded at the
facility. We estimate that these outsourcing facilities will submit a
total of approximately 50 reports in December and 50 reports in June
containing the information specified in the draft revised guidance
(``total annual responses'' in table 2, row 1). We estimate that
preparing and submitting this information electronically will take
approximately 2 hours per report (``average burden per response'' in
table 2, row 1). We expect to receive no more than one waiver request
from the electronic submission process (``total annual responses'' in
table 2, row 2), and each request should take approximately 1 hour to
prepare and submit to us (``average burden per response'' in table 2,
row 2).
[[Page 69859]]
Table 1--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of Average
compounding outsourcing Number of responses per Total annual burden per Total hours
facilities respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Submission of Initial Product 50 1 50 2 100
Report.........................
Waiver Request from Electronic 1 1 1 1 1
Submission of Initial Product
Report.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 101
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of
compounding outsourcing Number of responses per Total annual Average burden Total hours
facilities respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submission of December Product 50 1 50 2 100
Report.........................
Submission of June Product 50 1 50 2 100
Report.........................
Waiver Request from Electronic 1 1 1 1 1
Submission of Product Reports..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 201
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Comments
Interested persons can 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
can be viewed at 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27691 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P
