82 FR 27493 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

Page Range		27493-27496
FR Document		2017-12353

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).

Federal Register, Volume 82 Issue 114 (Thursday, June 15, 2017)

[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27493-27496]
From the Federal Register Online [www.thefederalregister.org]
[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.

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

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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of recordkeeping Number of records per Total annual Average burden per record Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of small business designation letter... 15 1 15 .5 (30 minutes)........................... 7.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices 27495

requires an outsourcing facility to facility of FDA’s decision. Outsourcing respondents’’ in table 2, row 2) annually
submit its written request for a small facilities eligible to pay a reduced fee will submit to FDA a request for
business reduction in a format specified should maintain a copy of the small reconsideration as described in the
by FDA in the guidance. The guidance business designation letter applicable to guidance. We estimate that it will take
specifies that Form FDA 3908 is the that fiscal year for their records. an outsourcing facility approximately 1
format for submitting requests for a We estimate that annually a total of 15 hour to prepare and submit to FDA each
small business fee reduction. outsourcing facilities (‘‘number of request for reconsideration (‘‘average
We estimate that annually a total of 15 recordkeepers’’ in table 3) will keep a burden per response’’ in table 2, row 2).
outsourcing facilities (‘‘number of copy of their small business designation As described in section V.B of the
respondents’’ in table 1, row 2) will letter (‘‘total annual records’’ in table 3), guidance, an outsourcing facility may
submit to FDA a request for a small and that maintaining each record will appeal, as set forth in § 10.75, an FDA
business reduction in the amount of the take 0.5 hour (‘‘average burden per denial of a request for reconsideration of
annual establishment fee. We estimate recordkeeping’’ in table 3). an FDA decision related to the fee
that 15 outsourcing facilities will submit As described in section V.B of the provisions of section 744K of the FD&C
Form FDA 3908 (‘‘total annual guidance, an outsourcing facility may Act.
responses’’ in table 1, row 2) to FDA request reconsideration under 21 CFR We estimate that a total of one
annually, as described in the guidance, 10.75 of an FDA decision related to the outsourcing facility (‘‘number of
and that it will take an outsourcing fee provisions of section 744K of the respondents’’ in table 2, row 3) annually
facility 25 hours to prepare and submit FD&C Act. As explained in the will submit an appeal of an FDA denial
to FDA each Form FDA 3908 (‘‘average guidance, the request should state the of a request for reconsideration. We
burden per response’’ in table 1, row 2). facility’s rationale for its position that estimate that it will take an outsourcing
As described in section III.D of the the decision was in error and include facility 1 hour to prepare and submit
guidance, those outsourcing facilities any additional information that is each appeal under § 10.75 (‘‘average
that request a small business reduction relevant to the outsourcing facility’s burden per response’’ in table 2, row 3).
in the amount of the annual argument. The estimated reporting and
establishment fee will receive a small We estimate that a total of three recordkeeping burdens for this
business designation letter notifying the outsourcing facilities (‘‘number of collection of information are as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—ESTABLISHMENT FEE 1
Number of
Number of Total annual Average burden
Type of reporting responses per Total hours
respondents responses per response
respondent

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).

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
Number of Total annual Average burden
Type of reporting responses per Total hours
respondents responses per response
respondent

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
Number of
Number of Total annual Average burden
Type of recordkeeping records per Total hours
recordkeepers records per record
recordkeeper

Copy of small business designation letter ............... 15 1 15 .5 (30 minutes) .......... 7.50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Document Created: 2017-06-15 01:03:25
Document Modified: 2017-06-15 01:03:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 14, 2017.
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]
FR Citation		82 FR 27493

82 FR 27493 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 114 (June 15, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration