
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48090-48092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0329]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Fees for Human Drug Compounding Outsourcing Facilities Under the 
Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 written comments on the collection of information by 
November 15, 2017.

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 0910-0776. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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.

Guidance for Industry on Fees for Human Drug Compounding Outsourcing 
Facilities Under Sections 503B and 744K of the FD&C Act OMB Control 
Number 0910-0776--Extension

    This information collection supports the Agency's guidance on fees 
for human drug compounding outsourcing facilities under the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act). On November 27, 2013, the 
President signed the Drug Quality and Security Act (DQSA) (Pub. L. 113-
54) into law. The DQSA added a new section, 503B (21 U.S.C. 353B), to 
the FD&C Act, creating 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 requirements 
described in section 503B, including registering with FDA as an 
outsourcing facility and paying associated fees. Drug products 
compounded in an outsourcing facility can qualify for exemptions from 
the FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 
355), and the requirement to label products with adequate directions 
for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), 
if the requirements in section 503B of the FD&C Act are met.
    The guidance is intended for entities that compound human drugs and 
elect to register as outsourcing facilities under section 503B of the 
FD&C Act. Once an entity has elected to register as an outsourcing 
facility, it must pay certain fees to be registered as an outsourcing 
facility. The guidance describes the types and amounts of fees that 
outsourcing facilities must pay, the adjustments to fees required by 
law, the way in which outsourcing facilities may submit payment to FDA, 
the consequences of outsourcing facilities' failure to pay fees, and 
the way an outsourcing facility may qualify as a small business to 
obtain a reduction in fees.
    In the Federal Register of June 15, 2017 (82 FR 27493), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received. 
We therefore estimate the burden associated with the information 
collection as follows:

[[Page 48091]]



                        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                          60               1              60    .5 (30 minutes)              30
 establishment fee...........
Request for Small Business                 15               1              15                 25             375
 Establishment Fee Reduction
 (Form FDA 3908).............
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................             405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


        Table 2--Estimated Annual Reporting Burden--Re-Inspection 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.              15               1              15    .5 (30 minutes)            7.50
Reconsideration request......               3               1               3                  1               3
Appeal request...............               1               1               1                  1               1
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  .................           11.50
----------------------------------------------------------------------------------------------------------------
\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
    Type of recordkeeping         Number of      record per     Total annual    Average  burden     Total hours
                                recordkeepers   recordkeeper       records        per  record
----------------------------------------------------------------------------------------------------------------
Copy of small business                     15               1              15    .5 (30 minutes)            7.50
 designation letter..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As described in section III.A of the 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 
guidance. This process would be repeated annually under the timeframes 
described in the 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 60 outsourcing facilities 
(``no. of respondents'' in table 1, row 1) will pay to FDA 60 
establishment fees (``total annual responses'' in table 1, row 1) as 
described in the guidance. We also estimate that it will take an 
outsourcing facility 0.5 hour to prepare and submit to FDA each 
establishment fee (``average burden per response'' in table 1, row 1).
    As described in section III.C of the guidance, outsourcing 
facilities that are re-inspected will be assessed a re-inspection fee 
for each re-inspection. The re-inspection 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 re-
inspection fee will be incurred for each re-inspection that occurs. 
After FDA conducts a re-inspection, we will send an invoice to the 
email address indicated in the facility's registration file. The 
invoice contains instructions for paying the re-inspection fee, as 
discussed in section III.E of the guidance.
    We estimate that annually a total of 15 outsourcing facilities 
(``no. of respondents'' in table 2, row 1) will pay to FDA 15 re-
inspection fees (``total annual responses'' in table 2, row 1) as 
described in the guidance. We also estimate that it will take an 
outsourcing facility 0.5 hour to prepare and submit to FDA each re-
inspection fee (``average burden per response'' in table 2, row 1).
    As described in section III.D of the 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 certifying 
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 fiscal year. For example, an outsourcing 
facility must submit a written request for the small business reduction 
by April 30, 2015, to qualify for a reduction in the fiscal year 2016 
annual establishment fee. As described in the guidance, section 744K of 
the FD&C Act (21 U.S.C. 379j-62) 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 guidance specifies that 
Form FDA 3908 is the format for submitting requests for a small 
business fee reduction.
    We estimate that annually a total of 15 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 15 outsourcing facilities will 
submit Form FDA 3908 (``total annual responses'' in table 1, row 2) to 
FDA annually, as described in the guidance, and that it will take an 
outsourcing facility 25 hours to prepare and submit to FDA each Form 
FDA 3908 (``average burden per response'' in table 1, row 2).

[[Page 48092]]

    As described in section III.D of the 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 15 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 0.5 hour (``average burden per 
recordkeeping'' in table 3).
    As described in section V.B of the guidance, an outsourcing 
facility may request 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 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 three outsourcing facilities (``no. of 
respondents'' in table 2, row 2) annually will submit to FDA a request 
for reconsideration as described in the guidance. We estimate 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).
    As described in section V.B of the guidance, an outsourcing 
facility may appeal, as set forth in Sec.  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 one outsourcing facility (``no. of 
respondents'' in table 2, row 3) annually will submit an appeal of an 
FDA denial of a request for reconsideration. We estimate that it will 
take an outsourcing facility 1 hour to prepare and submit each appeal 
under Sec.  10.75 (``average burden per response'' in table 2, row 3).

    Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22283 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P


