[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]


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

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Quality; Draft Guidance for Industry; Availability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.

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

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the availability of a draft guidance for industry entitled ``CDER's 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this draft guidance to obtain public comments on the proposed program.

DATES: Submit either electronic or written comments on the draft 
guidance by April 15, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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concerning the collection of information proposed in the draft guidance 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,

[[Page 4077]]

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

[[Page 4078]]

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for recognition of a voluntary consensus standard..........               9                1                9                1                9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4164-01-P