Document ID: FDA-2013-N-1429-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; 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: 2014-08-27T04:00Z

[Federal Register Volume 79, Number 166 (Wednesday, August 27, 2014)]
[Notices]
[Pages 51176-51178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20276]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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.

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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 (the PRA).

DATES: Fax written comments on the collection of information by 
September 26, 2014.

[[Page 51177]]

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 oirasubmission@omb.eop.gov. 
All comments should be identified with the title. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 Registration of Human Drug Compounding 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Availability

    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announced the availability of a draft guidance for industry entitled 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.'' The 
guidance is being issued to implement provisions added to the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) by the Drug Quality and 
Security Act (DQSA), which created a statutory category of 
``outsourcing facilities'' that compound human drugs. Section 503B of 
the FD&C Act (21 U.S.C. 353b) allows compounders to register with FDA 
as outsourcing facilities. 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 are met. The guidance discusses the process for registration of 
outsourcing facilities.
    Under the guidance, facilities that elect to register must 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 (21 U.S.C. 356e); and
     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.
    After initial registration, outsourcing facilities that wish to 
remain an outsourcing facility must re-register annually between 
October 1 and December 31 of each year. 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.'' In the 
draft guidance issued on December 4, 2013, FDA described an alternative 
interim registration mechanism for use after initial passage of the 
DQSA and until September 30, 2014. The final guidance specifies the use 
of the SPL format for all registrations. 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 for the person 
requesting the waiver.
    In response to the December 4, 2013, Federal Register notice, FDA 
received nine comments on the draft guidance, several of which raised 
issues pertaining to the information collection provisions in the draft 
guidance. The four primary issues raised are addressed below.
    (Issue 1) Several commenters noted that the final guidance should 
clarify what product information will be included on the public list of 
registered outsourcing facilities required under section 
503B(b)(1)(B)(ii) of the FD&C Act. Specifically, page 4, lines 133-134, 
of the draft guidance state that ``information collected from the 
outsourcing facility registration, as well as certain product 
information, will be published in a list'' authorized under section 
503B(b)(1)(B)(ii) of the FD&C Act. The commenters requested assurances 
that confidential information submitted in product reports would remain 
confidential and not be posted on the Web. Other commenters requested 
clarification about how often the information will be updated.
    (Response) FDA has clarified the guidance. Specifically, the 
guidance now reads: ``Section 503B(b)(1)(B)(ii) of the FD&C Act 
requires FDA to publish on the Internet a list of registered 
outsourcing facilities that includes the name of each registered 
outsourcing facility, the state in which it is located, whether the 
facility compounds from bulk drug substances and whether such 
compounding from bulk drug substances is for sterile or non-sterile 
drugs. FDA will publish the information required, as well as the date 
of registration as an outsourcing facility and certain publicly 
disclosable information related to past FDA inspections and compliance 
actions. FDA intends to update the list of registered outsourcing 
facilities weekly.''
    Some of the commenters may have been confusing disclosure of 
registration information with disclosure of proprietary information 
required to be reported under section 503B(b)(2) of the FD&C Act. That 
provision specifies that, upon initially registering as an outsourcing 
facility, once during the month of June of each year, and once during 
the month of December of each year, each facility that registers with 
the Secretary of Health and Human Services as an outsourcing facility 
shall submit to the Secretary a report providing certain information 
about the drugs that were compounded by the facility during the 
previous 6-month period. Unlike section 503B(b)(1), section 503B(b)(2) 
of the FD&C Act does not require that information reported be posted 
and specifies that reports submitted under the provision shall be 
exempt from inspection unless the Secretary finds that such an 
exemption would be inconsistent with the protection of the public 
health (section 503B(b)(2)(C) of the FD&C Act). FDA intends to address 
product reporting information in a separate guidance, ``Electronic 
Product Reporting for Human Drug Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act.'' At this time, FDA does not intend 
to routinely disclose such information.
    (Issue 2) Another commenter noted that all registration information 
from the outsourcing facility should be made public using the SPL 
format. The commenter suggested FDA obtain and make publicly available 
the following information: Name/license number of supervising 
pharmacist(s), an indicator of compliance registration or date of first 
and last registration, and a link to FDA disciplinary actions and to a 
list of recalled products for that outsourcing facility.
    (Response) The list of registered outsourcing facilities includes 
most of the information that the commenter suggested, including each 
facility's date of registration as an outsourcing facility and any 
action FDA has taken based on the most recent inspection. FDA publishes 
drug product recalls in its

[[Page 51178]]

weekly Enforcement Report, which includes a description of the products 
subject to the recall. The commenter can check the Enforcement Report 
to view drug products that have been recalled. FDA does not include the 
name/license number of the supervising pharmacist because section 503B 
of the FD&C Act does not require facilities to provide this information 
to FDA when registering. This information is not in SPL format because 
FDA includes information in this list that is not captured in SPL, such 
as FDA regulatory actions.
    (Issue 3) One commenter requested insight on how FDA intends to 
communicate with industry those facilities that had previously 
registered as human drug compounders before the implementation of 
section 503B and those that are now registering under section 503B of 
the FD&C Act.
    (Response) FDA has made available on the Internet a list of the 
facilities that have registered under section 503B of the FD&C Act as 
outsourcing facilities. FDA does not have a list of facilities that had 
previously registered as human drug compounders before section 503B of 
the FD&C Act was enacted as there was no category of registered human 
drug compounder before this. Some human drug compounding facilities may 
have registered prior to the enactment of section 503B as human drug 
manufacturers under section 510 of the FD&C Act (21 U.S.C. 360). A list 
of all firms that are registered as manufacturers under section 510 is 
available to the public on FDA's Drug Establishments Current 
Registration Site, which is separate from the list of outsourcing 
facilities that have registered under section 503B of the FD&C Act.
    (Issue 4) Another commenter noted that FDA should define what would 
constitute an undue burden justifying the granting of a waiver from the 
submission of registration information electronically.
    (Response) Section 503B(b)(3) of the FD&C Act specifies the 
standard FDA is to use to determine whether a waiver should be granted. 
FDA may grant a waiver if it finds that ``use of electronic means is 
not reasonable for the person requesting the waiver.'' FDA does not 
anticipate many instances in which electronic submission of 
registration information will not be reasonable for the person 
requesting the waiver, because the information requested is minimal, 
and the electronic system for submitting the information is an 
Internet-based system accessible to all firms seeking to register. 
Because human drug compounders are not currently required to register 
and report as outsourcing facilities, it is difficult to anticipate the 
number of outsourcing facilities that will participate in the process.
    As a result of comments received on the ``Draft Guidance for 
Industry on Fees for Human Drug Compounding Outsourcing Facilities 
Under the Federal Food, Drug, and Cosmetic Act,'' FDA has increased its 
estimates of the number of outsourcing facilities that are subject to 
each guidance. We now estimate that 50 outsourcing facilities will 
register and pay establishment fees, and we have adjusted the other 
estimates in the table (except for the ``average burden per response'') 
accordingly.
    We estimate that 50 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 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 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:

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                                                     Number of                        Average
Compounding outsourcing facility     Number of     responses per   Total annual     burden per     Total  hours
                                    respondents     respondent       responses       response
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Electronic Submission of                      50               1              50             4.5             225
 Registration Information Using
 SPL Format.....................
Waiver Request From Electronic                 1               1               1               1               1
 Submission of Registration
 Information....................
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    Total.......................  ..............  ..............  ..............  ..............             226
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: August 21, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20276 Filed 8-26-14; 8:45 am]
BILLING CODE 4164-01-P