Document ID: FDA-2013-N-1429-0015
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Posted Date: 2017-06-20T04:00Z

[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28076-28078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12838]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]

Agency Information Collection Activities: Proposed Collection; 
Comment Request; Guidance for Industry on Registration of Human Drug 
Compounding Outsourcing Facilities Under Section 503B of 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 registration of human drug compounding outsourcing facilities under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by August 21, 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 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 21, 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

[[Page 28077]]

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2013-N 1429 for ``Guidance for Industry on Registration of Human 
Drug Compounding Outsourcing Facilities Under Section 503B 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 Dockets Management 
Staff 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 for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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 Dockets Management Staff, 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 Registration of Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act: OMB Control Number 0910-0777--Extension

    A facility that compounds drugs may elect to register with FDA as 
an outsourcing facility under section 503B of the FD&C Act (21 U.S.C. 
353b), as added by the Drug Quality and Security Act (DQSA). Drug 
products compounded in a registered outsourcing facility can qualify 
for exemptions from the FDA approval requirements in section 505 of the 
FD&C Act (21 U.S.C. 355), 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)), and drug supply chain security requirements in 
section 582 of the FD&C Act (21 U.S.C. 360eee) if the requirements in 
section 503B are met.
    After the initial registration, under section 503B(b) of the FD&C 
Act, a facility that elects to register with FDA as an outsourcing 
facility must also do so annually between October 1 and December 31. 
Upon registration, the outsourcing facility must provide its name, 
place of business, a unique facility identifier, and a point of contact 
email address. The outsourcing facility must also indicate whether it 
intends to compound, within the next calendar year, a drug that appears 
on FDA's drug shortage list in effect under section 506E of the FD&C 
Act (21 U.S.C. 356e), and whether it compounds from bulk drug 
substances, and, if so, whether it compounds sterile or non-sterile 
drugs from bulk drug substances.
    Outsourcing facilities that elect to register should submit the 
following registration information to FDA for each facility:
     Name of the facility;
     Place of business;
     Unique facility identifier;
     Point of contact email address and phone number;
     Whether the facility intends to compound drugs that appear 
on FDA's drug shortage list in effect under section 506E of the FD&C 
Act; and

[[Page 28078]]

     An indication of whether the facility compounds from bulk 
drug substances, and if so, whether it compounds sterile or nonsterile 
drugs from bulk drug substances.
    Registration information should be submitted to FDA electronically 
using the Structured Product Labeling (SPL) format and in accordance 
with section IV of the FDA guidance entitled ``Providing Regulatory 
Submissions in Electronic Format--Drug Establishment Registration and 
Drug Listing.'' Under the final guidance, outsourcing facilities may 
request a waiver from the SPL electronic submission process by 
submitting a written request to FDA explaining why the use of 
electronic means is not reasonable.
    This information collection supports the Agency guidance discussed 
above. We estimate that approximately 62 outsourcing facilities 
(``number of respondents'' and ``total annual responses'' in table 1, 
row 1) will annually submit to FDA registration information using the 
SPL format as specified in the guidance, and that preparing and 
submitting this information will take approximately 4.5 hours per 
registrant (``average burden per response'' in table 1, row 1). We 
expect to receive no more than one waiver request from the electronic 
submission process annually (``number of respondents'' and ``total 
annual responses'' in table 1, row 2), and that each request should 
take approximately 1 hour to prepare and submit to us (``average burden 
per response'' in table 1, row 2).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Compounding  outsourcing         Number of    responses  per   Total annual     burden per      Total hours
            facility                respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
Electronic Submission of                      62               1              62             4.5             279
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning Legislation, and Analysis.
[FR Doc. 2017-12838 Filed 6-19-17; 8:45 am]
 BILLING CODE 4164-01-P