[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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collection of information proposed in the draft guidance by June 2, 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
        Type of reporting            Number of    responses  per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
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)................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             260
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Type of reporting           Number of    responses  per   Total annual    Average burden    Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
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
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ...............              5.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of        Number of records       Total annual      Average burden per
             Type of recordkeeping                  recordkeepers       per recordkeeper         records           recordkeeping         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of small business designation letter......                  10                    1                   10                  0.5                    5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P