Friday, November 21, 2014

High Importance: Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities;

4164-01-P DEPARTMENT OF HEALTH AND HUMAN ...

www.ofr.gov/.../OFRUpload/OFRData/2014-27691_PI.pdf
2 hours ago - Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; ... must report information on the drugs they have compounded in Structured.

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4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft
Guidance
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the
availability of a revised draft guidance entitled “Electronic Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and
Cosmetic Act.” The revised draft guidance addresses provisions in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates
reporting instructions for drug compounders that choose to register as outsourcing facilities.
Such compounders must report information on the drugs they have compounded in Structured
Product Labeling (SPL) format using FDA’s electronic submissions system. This revised draft
guidance supersedes a draft guidance entitled “Interim Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and
Cosmetic Act.”
DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)),
to ensure that the Agency considers your comments on this revised draft guidance, submit either
electronic or written comments on the revised draft guidance by [INSERT DATE 60 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Submit either electronic
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or written comments concerning the collection of information proposed in the revised draft
guidance by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
ADDRESSES: Submit written requests for single copies of the revised draft guidance document
to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic access to the
revised draft guidance.
Submit electronic comments on the revised draft guidance to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002, 301-796-3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for industry entitled
“Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act.” In the Federal Register of
December 4, 2013 (78 FR 72897), FDA issued a notice announcing the availability of an initial
draft of this guidance entitled “Interim Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” That
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draft guidance addressed new provisions in the FD&C Act added by the DQSA and set forth an
interim submission method for human drug compounders that choose to register as outsourcing
facilities.
The comment period on the initial draft guidance ended on February 3, 2014. FDA
received six comments on the draft. In response to received comments or on its own initiative,
FDA made the following changes and updates in the revised draft guidance: (1) Modified the
scope of the guidance to refer to product reports submitted in SPL format; (2) clarified the
following elements required in a product report: “Strength of the active ingredient per unit,”
“package description,” and “number of individual units produced”; (3) included language that
discusses the time period during which outsourcing facilities must submit product reports; (4)
included the appropriate SPL document type category for outsourcing facilities submitting a
product report and a reference to detailed instructions on how to submit information using SPL;
(5) clarified that reports submitted under section 503B(b)(2) of the FD&C Act (21 U.S.C.
353b(b)(2)) are exempt from inspection unless the Secretary finds that such an exemption would
be inconsistent with the protection of the public health; and (6) made grammatical and other
minor editorial changes for clarity.
In some cases, received comments raised issues that were not directly pertinent to the
topics addressed in the draft. This revised draft guidance explains that registered outsourcing
facilities must provide reports to FDA on compounded drugs in SPL format using FDA’s
electronic submissions system. It supersedes the draft guidance entitled “Interim Product
Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.”
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Section 503B(b)(2)(B) of the FD&C Act provides that a facility that elects to register
with FDA as an outsourcing facility is required to report to FDA information about the drugs
compounded at that outsourcing facility in the form and manner as FDA may “prescribe by
regulation or guidance.” Congress gave FDA explicit statutory authority to establish binding
requirements on this topic in guidance. Therefore, this guidance is not subject to the usual
restrictions in FDA's good guidance practice regulations (e.g., the requirements that guidances
not establish legally enforceable responsibilities and that guidances prominently display a
statement of the document's nonbinding effect); see 21 CFR 10.115(d)(1)).
As provided in section 503B of the DQSA, this revised draft guidance explains the form
and manner in which registered outsourcing facilities are required to submit drug reporting
information. This revised draft guidance, when finalized, will prescribe the form and manner for
submitting drug product reports to FDA under section 503B of the FD&C Act and will have
binding effect under section 503B(b)(2)(B). Until this draft guidance is finalized, FDA will
accept drug product reports submitted in accordance with the form and manner described in
FDA’s initial draft guidance on this subject. However, FDA strongly encourages outsourcing
facilities to submit drug product reports as described in this revised draft guidance.
Elsewhere in this issue of the Federal Register, FDA is making available a final guidance
on registration for human drug compounding outsourcing facilities under section 503B of the
FD&C Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (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 that they conduct or sponsor. “Collection of information” is defined in
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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 for each proposed collection of information
before submitting the collection to OMB for approval. To comply with this requirement, FDA is
publishing this notice of the proposed collection of information set forth in this document.
With respect to the collection of information associated with this document, FDA invites
comments on the following topics: (1) Whether the proposed information collected is necessary
for the proper performance of FDA’s functions, including whether the information will have
practical utility; (2) the accuracy of FDA’s estimated burden of the proposed information
collected, including the validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden
of information collected on the respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information technology.
Under the revised draft guidance, registered outsourcing facilities must submit to FDA a
report identifying all drugs compounded by the facility during the previous 6-month period. The
report must be submitted upon initial registration as an outsourcing facility, once in June, and
once in December of each year. The report must include the following information for all drugs
compounded at the outsourcing facility during the previous 6-month period:
• The active ingredient and strength of active ingredient per unit
• The source of the active ingredient (bulk or finished)
• The National Drug Code (NDC) number of the source drug or bulk active
ingredient, if available
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• The dosage form and route of administration
• The package description
• The number of individual units produced
• The NDC number of the final product, if assigned
Product reports must be submitted to FDA electronically in SPL format, as described in
the revised draft guidance. Outsourcing facilities can request a waiver from the electronic
submission process by submitting a written request to FDA explaining why the use of electronic
means is not reasonable for them.
Based on our familiarity with outsourcing facilities, we estimate that annually a total of
approximately 50 outsourcing facilities (“number of respondents” in table 1, row 1) will submit
to FDA at the time of initial registration a report identifying all drugs compounded in the facility.
We also estimate that these outsourcing facilities will submit a total of approximately 50 reports
for compounded drugs containing the information specified in the draft guidance (“total annual
responses” in table 1, row 1). We estimate that preparing and submitting this information
electronically will take approximately 2 hours per report (“average burden per response” in table
1, row 1). We expect to receive no more than one waiver request from this electronic submission
process (“total annual responses” in table 1, row 2), and each request should take approximately
1 hour to prepare and submit to us (“average burden per response” in table 1, row 2).
We also estimate that a total of approximately 50 outsourcing facilities (“number of
respondents” in table 2, row 1) will submit to FDA a report twice each year identifying all drugs
compounded at the facility. We estimate that these outsourcing facilities will submit a total of
approximately 50 reports in December and 50 reports in June containing the information
specified in the draft revised guidance (“total annual responses” in table 2, row 1). We estimate
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that preparing and submitting this information electronically will take approximately 2 hours per
report (“average burden per response” in table 2, row 1). We expect to receive no more than one
waiver request from the electronic submission process (“total annual responses” in table 2, row
2), and each request should take approximately 1 hour to prepare and submit to us (“average
burden per response” in table 2, row 2).
Table 1.--Estimated One-Time Reporting Burden1
Product
Reporting for
Compounding
Outsourcing
Facilities
No. of
Respondents
No. of
Responses per
Respondent
Total Annual
Responses
Average Burden
per Response
Total Hours
Submission of
Initial Product
Report
50
1
50
2
100
Waiver Request
from Electronic
Submission of
Initial Product
Report
1
1
1
1
1
Total
101
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Reporting Burden1
Product
Reporting for
Compounding
Outsourcing
Facilities
No. of
Respondents
No. of
Responses per
Respondent
Total Annual
Responses
Average Burden
per Response
Total Hours
Submission of
December
Product Report
50
1
50
2
100
Submission of
June Product
Report
50
1
50
2
100
Waiver Request
from Electronic
Submission of
Product Reports
1
1
1
1
1
Total
201
1There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
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Interested persons can submit either electronic comments regarding this document to
http://www.regulations.gov or written comments to the Division of Dockets Management (see
ADDRESSES). It is only necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document. Received comments can be
viewed at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through
Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at either
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov.
Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27691 Filed 11/21/2014 at 8:45 am; Publication Date: 11/24/2014]
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