[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27493-27496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection in the guidance 
on Fees for Human Drug Compounding Outsourcing Facilities Under the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by August 14, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 14, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-D-0329 for ``Guidance for Industry on Fees for Human Drug 
Compounding Outsourcing Facilities Under Sections 503B and 744K of the 
Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available

[[Page 27494]]

for public viewing and posted on https://www.regulations.gov. Submit 
both copies to the Division of Dockets Management. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under 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 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 concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites 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.

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

    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.
    The guidance contains the following collections 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 
(``number 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 
(``number 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

[[Page 27495]]

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 
(``number 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).
    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 
(``number 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 (``number 
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 (``number 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).
    The estimated reporting and recordkeeping burdens for this 
collection of information are as follows:

                                            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 per response           Total hours
                                                respondents     respondent       responses
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Payment of annual establishment fee.........              60               1              60  .5 (30 minutes)...........................              30
Request for Small Business Establishment Fee              15               1              15  25........................................             375
 Reduction (FDA Form 3908).
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    Total...................................  ..............  ..............  ..............  ..........................................             405
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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--Re-Inspection Fee and Dispute Resolution Requests \1\
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                                                                 Number of
              Type of reporting                  Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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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
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    Total...................................  ..............  ..............  ..............  ..........................................           11.50
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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
            Type of recordkeeping                Number of      records per    Total annual            Average burden per record            Total hours
                                               recordkeepers   recordkeeper       records
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Copy of small business designation letter...              15               1              15  .5 (30 minutes)...........................            7.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 27496]]

    Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12353 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P