[Federal Register Volume 79, Number 62 (Tuesday, April 1, 2014)]
[Notices]
[Pages 18297-18299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06884]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0329]
Guidance for Industry on Fees for Human Drug Compounding
Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Fees for Human Drug
Compounding Outsourcing Facilities Under Sections 503B and 744K of the
FD&C Act.'' The guidance is intended for entities that compound human
drugs and elect to register as outsourcing facilities (outsourcing
facility) under section 503B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA).
Entities that elect to register as outsourcing facilities must pay
certain fees to be considered outsourcing facilities. This guidance
describes the annual establishment fee, the reinspection fee, annual
adjustments to fees required by law, how to submit payment, the effect
of failure to pay fees, and how to qualify as a small business to
obtain a reduction of the annual establishment fee.
DATES: Submit either electronic or written comments on FDA guidances at
any time. Submit either electronic or written comments concerning the
collection of information proposed in the draft guidance by June 2,
2014.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of User Fee Management and Budget Formulation, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 2163, Silver Spring, MD 20903. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
Submit electronic comments on the guidance to http://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: M. Jonathan Gil, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Silver Spring, MD 20903, 301-796-7900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under
Sections 503B and 744K of the FD&C Act.'' On November 27, 2013,
President Obama signed the DQSA (Pub. L. 113-54) into law. The DQSA
added a new section 503B to the FD&C Act that created a category of
entities called outsourcing facilities. Outsourcing facilities, as
defined in section 503B(d)(4) of the FD&C Act, are facilities that meet
certain conditions described in section 503B(a), including, registering
with FDA as an outsourcing facility and paying associated fees. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from two sections of
the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
the labeling of drugs with adequate directions for use); and (2)
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current 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(a)(9)
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 fee-related
dispute resolution.
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 this topic. 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. Paperwork Reduction Act of 1995
This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection are given under this section with an estimate of the
reporting and recordkeeping burden. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Guidance for Industry on Fees for Human Drug Compounding
Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act;
Availability.
Description: The draft guidance pertains to entities that compound
human drugs and elect to register as outsourcing facilities. These
outsourcing facilities must pay certain fees to FDA. The draft guidance
describes the fee
[[Page 18298]]
types and amounts, the adjustments to fees required by law, how to
submit payment, the effect of failure to pay fees, and how to qualify
as a small business to obtain a reduction of the annual establishment
fee. The draft guidance contains the following collections of
information:
1. As described in section III.A of the draft guidance, upon
receiving registration information from a facility seeking to register
as an outsourcing facility, FDA will send an invoice for an
establishment fee to the outsourcing facility. The invoice contains
instructions for paying the establishment fee, as discussed in section
III.E of the draft guidance. This process would be repeated annually
under the timeframes described in the draft guidance. An outsourcing
facility is not considered registered until the required establishment
fee is paid for that fiscal year.
We estimate that annually a total of approximately 20 outsourcing
facilities (``no. of respondents'' in table 1, row 1) will pay to FDA
approximately 20 establishment fees (``total annual responses'' in
table 1, row 1) as described in the draft guidance. We also estimate
that it will take an outsourcing facility approximately 0.5 hours to
prepare and submit to FDA each establishment fee (``average burden per
response'' in table 1, row 1).
2. As described in section III.C of the draft guidance, outsourcing
facilities that are reinspected will be assessed a reinspection fee for
each reinspection. The reinspection fee is designed to reimburse FDA
when it must visit a particular outsourcing facility more than once
because of noncompliance identified during a previous inspection. A
reinspection fee will be incurred for each reinspection that occurs.
After FDA conducts a reinspection, we will send an invoice to the email
address indicated in the facility's registration file. The invoice
contains instructions for paying the reinspection fee, as discussed in
section III.E of the draft guidance.
We estimate that annually a total of approximately 5 outsourcing
facilities (``no. of respondents'' in table 2, row 1) will pay to FDA
approximately 5 reinspection fees (``total annual responses'' in table
2, row 1) as described in the draft guidance. We also estimate that it
will take an outsourcing facility approximately 0.5 hours to prepare
and submit to FDA each reinspection fee (``average burden per
response'' in table 2, row 1).
3. As described in section III.D of the draft guidance, certain
outsourcing facilities may qualify for a small business reduction in
the amount of the annual establishment fee. To qualify for this
reduction, an outsourcing facility must submit to FDA a written request
and a certification that the entity meets the requirements for the
reduction. For every fiscal year that the firm seeks to qualify as a
small business and receive the fee reduction, the written request must
be submitted to FDA by April 30 of the preceding the fiscal year. For
example, an outsourcing facility must submit a written request for the
small business reduction by April 30, 2014, to qualify for a reduction
in the fiscal year 2015 annual establishment fee. As described in the
guidance, section 744K of the FD&C Act also requires an outsourcing
facility to submit its written request for a small business reduction
in a format specified by FDA in the guidance. The draft guidance
specifies that Form FDA 3908 is the format for submitting requests for
a small business fee reduction; Form FDA 3908 is attached as Appendix
1.
We estimate that annually a total of approximately 10 outsourcing
facilities (``no. of respondents'' in table 1, row 2) will submit to
FDA a request for a small business reduction in the amount of the
annual establishment fee. We estimate that approximately 10 Form FDA
3908 (``total annual responses'' in table 1, row 2) will be submitted
to FDA annually, as described in the draft guidance, and that it will
take an outsourcing facility approximately 25 hours to prepare and
submit to FDA each Form FDA 3908 (``average burden per response'' in
table 1, row 2).
4. As described in section III.D of the draft guidance, those
outsourcing facilities that request a small business reduction in the
amount of the annual establishment fee will receive a small business
designation letter notifying the facility of FDA's decision.
Outsourcing facilities eligible to pay a reduced fee should maintain a
copy of the small business designation letter applicable to that fiscal
year for their records.
We estimate that annually a total of approximately 10 outsourcing
facilities (``no. of recordkeepers'' in table 3) will keep a copy of
their small business designation letter (``total annual records'' in
table 3), and that maintaining each record will take approximately 0.5
hours (``average burden per recordkeeping'' in table 3).
5. As described in section V.B of the draft guidance, an
outsourcing facility may request a reconsideration under 21 CFR 10.75
of an FDA decision related to the fee provisions of section 744K of the
FD&C Act. As explained in the draft guidance, the request should state
the facility's rationale for its position that the decision was in
error and include any additional information that is relevant to the
outsourcing facility's argument.
We estimate that a total of approximately 2 outsourcing facilities
(``no. of respondents'' in table 2, row 2) will submit to FDA a request
for reconsideration as described in the draft guidance. We estimate
that approximately 1 request for reconsideration (``total annual
responses'' in table 2, row 2) will be submitted to FDA by each
facility, and that it will take an outsourcing facility approximately 1
hour to prepare and submit to FDA each request for reconsideration
(``average burden per response'' in table 2, row 2).
6. As described in section V.B of the draft guidance, an
outsourcing facility may appeal, as set forth in 21 CFR 10.75, an FDA
denial of a request for reconsideration of an FDA decision related to
the fee provisions of section 744K of the FD&C Act.
We estimate that a total of approximately 1 outsourcing facility
(``no. of respondents'' in table 2, row 3) will submit an appeal of an
FDA denial of a request for reconsideration. We estimate that
approximately 1 appeal will be made by each facility containing the
information described in the draft guidance (``total annual responses''
in table 2, row 3), and that it will take an outsourcing facility
approximately 1 hour to prepare and submit each appeal under 21 CFR
10.75 (``average burden per response'' in table 2, row 3).
In the Federal Register of December 4, 2013 (78 FR 72899), FDA
announced the availability of a draft guidance for industry entitled
``Registration for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' In that
notice, we estimated the burden under the PRA for submitting
outsourcing facility registration information to FDA.
The total estimated reporting and recordkeeping burdens for this
collection of information are as follows:
[[Page 18299]]
Table 1--Estimated Annual Reporting Burden--Establishment Fee \1\
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Number of
Type of reporting Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Payment of annual establishment 20 1 20 0.5 10
fee............................
Request for Small Business 10 1 10 25 250
Establishment Fee Reduction
(Form FDA 3908)................
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Total....................... .............. .............. .............. .............. 260
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden--Reinspection Fee and Dispute Resolution Requests \1\
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Number of
Type of reporting Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Payment of re-inspection fee.. 5 1 5 0.5 2.5
Reconsideration request....... 2 1 2 1 2
Appeal request................ 1 1 1 1 1
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Total..................... .............. .............. .............. ............... 5.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Recordkeeping Burden \1\
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Number of Number of records Total annual Average burden per
Type of recordkeeping recordkeepers per recordkeeper records recordkeeping Total hours
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Copy of small business designation letter...... 10 1 10 0.5 5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either electronic comments regarding
the guidance to http://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
may 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 http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm or http://www.regulations.gov. Use the FDA Web site
listed in the previous sentence to find the most current version of the
guidance.
Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06884 Filed 3-31-14; 8:45 am]
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