[Federal Register Volume 84, Number 31 (Thursday, February 14, 2019)]
[Notices]
[Pages 4076-4078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02326]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4417]
Center for Drug Evaluation and Research's Program for the
Recognition of Voluntary Consensus Standards Related to Pharmaceutical
Quality; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``CDER's
Program for the Recognition of Voluntary Consensus Standards Related to
Pharmaceutical Quality.'' This guidance describes a proposed program at
FDA's Center for Drug Evaluation and Research (CDER) to make public a
comprehensive listing of informally recognized voluntary consensus
standards related to pharmaceutical quality. This program, once
established, will facilitate submissions by external stakeholders and
CDER staff proposing voluntary consensus standards related to
pharmaceutical quality for informal recognition. CDER believes that
this informal program, which is different than the formal recognition
standards program in FDA's Center for Devices and Radiological Health,
will help promote innovation in pharmaceutical development and
manufacturing and streamline the compilation and assessment of
marketing applications for products regulated by CDER. CDER is issuing
this draft guidance to obtain public comments on the proposed program.
DATES: Submit either electronic or written comments on the draft
guidance by April 15, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
concerning the collection of information proposed in the draft guidance
by April 15, 2019.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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,
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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): 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-2018-D-4417 for ``CDER's Program for the Recognition of Voluntary
Consensus Standards Related to Pharmaceutical Quality.'' Received
comments 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 office 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance 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
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Colleen Thomas, Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4334, Silver Spring, MD 20993-0002,
301-796-4853.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``CDER's Program for the Recognition of Voluntary Consensus
Standards Related to Pharmaceutical Quality.'' This program, once
established, will facilitate submissions by external stakeholders and
CDER staff proposing voluntary consensus standards related to
pharmaceutical quality for informal recognition.
The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113) and Circular A-119 by the Office of Management and Budget
(OMB) have established Federal Government policies to improve the
internal management of the executive branch by directing agencies to
use voluntary consensus standards developed or adopted by a standards
developing organization--rather than Government-unique standards--
except where these standards are inconsistent with applicable law or
otherwise impractical. FDA's development and use of standards have been
integral to the execution of FDA's mission.
CDER believes that this informal program, which is different than
the formal recognition standards program in FDA's Center for Devices
and Radiological Health, will help promote innovation in pharmaceutical
development and manufacturing and streamline the compilation and review
of marketing applications for products regulated by CDER. CDER also
believes that this program will: (1) Allow CDER to communicate to
external stakeholders that its relevant expert(s) have evaluated a
consensus standard and determined if that standard is potentially
useful both to industry and CDER staff and (2) provide transparency to
industry regarding CDER's thinking about a method or approach.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on CDER's Program
for the Recognition of Voluntary Consensus Standards Related to
Pharmaceutical Quality. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520),
Federal Agencies must obtain approval from the 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 before submitting the
collection to OMB for approval. To comply with this
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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.
Request for Recognition of a Voluntary Consensus Standard
OMB Control Number 0910-NEW
The draft guidance for industry entitled ``CDER's Program for the
Recognition of Voluntary Consensus Standards Related to Pharmaceutical
Quality'' provides guidance to industry about the procedures the Center
for Drug Evaluation and Research follows when a request for recognition
of a voluntary consensus standard is received. The guidance outlines
justifications for why a standard may be recognized wholly, partly, or
not at all. The guidance also provides that any interested party may
request recognition of a standard. Specifically, this process will
allow CDER to:
Receive a candidate consensus standard, with relevant
information (e.g., the scope of the standard and the purpose), from
internal or external parties for informal recognition.
Determine whether to informally recognize a standard in
whole or in part following an internal scientific evaluation.
List the informally recognized standards in a publicly
searchable database on CDER's website, accompanied by an information
sheet describing the scope and the extent of CDER's informal
recognition of that standard and any other relevant information about
it.
Request for Recognition of a Voluntary Consensus Standard
We estimate that FDA will receive nine requests annually. We
estimate that each request will take less than 1 hour to prepare.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Request for recognition of a voluntary consensus standard.......... 9 1 9 1 9
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02326 Filed 2-13-19; 8:45 am]
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