81 FR 75351 - Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 210 (October 31, 2016)

Page Range		75351-75352
FR Document		2016-26244

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of August 24, 2016. In the proposed rule, FDA requested comments on its proposal to amend the regulations for good laboratory practice for nonclinical studies. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 81 Issue 210 (Monday, October 31, 2016)

[Federal Register Volume 81, Number 210 (Monday, October 31, 2016)]
[Proposed Rules]
[Pages 75351-75352]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-26244]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 58

[Docket No. FDA-2010-N-0548]

Good Laboratory Practice for Nonclinical Laboratory Studies;
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the
comment period for the proposed rule that appeared in the Federal
Register of August 24, 2016. In the proposed rule, FDA requested
comments on its proposal to amend the regulations for good laboratory
practice for nonclinical studies. The Agency is taking this action in
response to requests for an extension to allow interested persons
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule
published August 24, 2016 (81 FR 58342). Submit either electronic or
written comments by January 21, 2017.

ADDRESSES: You may submit comments as follows:

[[Page 75352]]

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0548 for ``Good Laboratory Practice for Nonclinical
Laboratory Studies.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Office of Surveillance
and Compliance, Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., MPN4-142, Rockville, MD 20855, 240-
402-5637; or Kristin Webster Maloney, Office of Policy and Risk
Management, Office of Regulatory Affairs, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 4373, Silver Spring, MD 20993,
240-402-4993.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 2016,
FDA published a proposed rule with a 90-day comment period to request
comments on its proposal to amend the regulations for good laboratory
practice for nonclinical studies. Comments on the proposed amendments
will inform FDA's rulemaking to establish regulations for good
laboratory practice for nonclinical laboratory studies.
The Agency has received requests for a 90-day extension of the
comment period for the proposed rule. Each request conveyed concern
that the current 90-day comment period does not allow sufficient time
to develop a meaningful or thoughtful response to the proposed rule.
FDA has considered the requests and is extending the comment period
for the proposed rule for 60 days, until January 21, 2017. The Agency
believes that a 60-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues.

Dated: October 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26244 Filed 10-28-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 210 / Monday, October 31, 2016 / Proposed Rules 75351

TABLE 1—THE FOUR FOUNDATIONAL FSMA RULES RELEVANT TO THE DRAFT GUIDANCE—Continued
Title and abbreviations for the purpose of this document Regulatory codification ‘‘Customer provisions’’ Publication

Current Good Manufacturing Practice, Hazard Analysis, 21 CFR part 507 ............... 21 CFR 507.36(a)(2), (3), 80 FR 56170, September
and Risk-Based Preventive Controls for Food for Ani- and (4). 17, 2015.
mals (part 507).
Standards for the Growing, Harvesting, Packing, and 21 CFR part 112 ............... 21 CFR 112.2(b) ............... 80 FR 74354, November
Holding of Produce for Human Consumption (produce 27, 2015.
safety regulation).
Foreign Supplier Verification Programs (FSVP) for Im- 21 CFR part 1, subpart L .. 21 CFR 1.507(a)(2)(i), 80 FR 74226, November
porters of Food for Humans and Animals (FSVP reg- (a)(3)(i), and (a)(4)(i). 27, 2015.
ulation).

The ‘‘customer provisions’’ of part of analysis, shipping documents, 1061, Rockville, MD 20852, and are
117 and part 507 each include a specifications, and terms and available for viewing by interested
requirement for a ‘‘disclosure conditions). persons between 9 a.m. and 4 p.m.,
statement’’ in which a manufacturer/ The trade association focused its Monday through Friday; they are also
processor must disclose, in documents discussion on the requirements of part available electronically at http://
accompanying the food, in accordance 117, but noted that it had parallel www.regulations.gov.
with the practice of the trade, that the concerns for the analogous provisions of 1. Grocery Manufacturers Association, ‘‘21
food is ‘‘not processed to control part 507 and the FSVP regulation (Ref. CFR 117.136. Industry Impacts from
[identified hazard]’’ in certain 1). Although the trade association did Disclosure and Written Assurance
circumstances. Likewise, the ‘‘customer not express concern with the disclosure Requirements,’’ 2016.
provisions’’ of the FSVP regulation statement in the produce safety
Dated: October 26, 2016.
include a requirement for a ‘‘disclosure regulation, we believe it will be helpful
Leslie Kux,
statement’’ in which an importer must to businesses subject to the produce
safety regulation, to include our current Associate Commissioner for Policy.
disclose, in documents accompanying
thinking on the disclosure statement in [FR Doc. 2016–26245 Filed 10–28–16; 8:45 am]
the food, in accordance with the
practice of the trade, that the food is all four rules that have requirements for BILLING CODE 4164–01–P

‘‘not processed to control [identified a disclosure statement, not just the three
hazard]’’ in certain circumstances. The rules mentioned by the trade
association. DEPARTMENT OF HEALTH AND
‘‘customer provisions’’ of the produce
HUMAN SERVICES
safety regulation relate to an exemption II. Paperwork Reduction Act of 1995
from that regulation that includes a Food and Drug Administration
This draft guidance refers to
requirement for a ‘‘disclosure
previously approved collections of
statement’’ in which a farm must 21 CFR Parts 16 and 58
information found in FDA regulations.
disclose, in documents accompanying
These collections of information are
the food, in accordance with the [Docket No. FDA–2010–N–0548]
subject to review by the Office of
practice of the trade, that the food is
Management and Budget (OMB) under
‘‘not processed to adequately reduce the Good Laboratory Practice for
the Paperwork Reduction Act of 1995
presence of microorganisms of public Nonclinical Laboratory Studies;
(44 U.S.C. 3501–3520). The collections
health significance.’’ Extension of Comment Period
of information in 21 CFR part 117 have
The draft guidance responds to
been approved under OMB control AGENCY: Food and Drug Administration,
industry questions regarding these
number 0910–0751. The collections of HHS.
requirements for a disclosure statement.
information in 21 CFR part 507 have Proposed rule; extension of
ACTION:
On March 23, 2016, FDA met with a been approved under OMB control
food trade association at their request to comment period.
number 0910–0789. The collections of
listen to concerns regarding the information in 21 CFR part 112 have
customer provisions of part 117 (Ref. 1), SUMMARY: The Food and Drug
been approved under OMB control Administration (FDA) is extending the
including concerns regarding the number 0910–0816. The collections of
disclosure statement in part 117. At the comment period for the proposed rule
information in 21 CFR part 1, subpart L that appeared in the Federal Register of
meeting, the trade association expressed have been approved under OMB control
concern about providing a disclosure August 24, 2016. In the proposed rule,
number 0910–0752. FDA requested comments on its
statement when multiple hazards may
be present, including chemical hazards III. Electronic Access proposal to amend the regulations for
(such as mycotoxins) and physical good laboratory practice for nonclinical
Persons with access to the Internet studies. The Agency is taking this action
hazards (such as stones in raw may obtain the draft guidance at either
agricultural commodities), as well as for in response to requests for an extension
http://www.fda.gov/FoodGuidances or to allow interested persons additional
multiple biological hazards (such as http://www.regulations.gov. Use the
microbial pathogens). The trade time to submit comments.
Lhorne on DSK30JT082PROD with PROPOSALS

FDA Web site listed in the previous
association also asked us to allow a DATES: FDA is extending the comment
sentence to find the most current
variety of types of documents that version of the guidance. period on the proposed rule published
accompany the food to have the August 24, 2016 (81 FR 58342). Submit
disclosure statement (e.g., contractual IV. References either electronic or written comments
agreements, Web sites referenced on The following references are on by January 21, 2017.
labels and in contracts, labels, letters of display in the Division of Dockets ADDRESSES: You may submit comments
guarantee, shipment-specific certificates Management, 5630 Fishers Lane, Rm. as follows:

VerDate Sep<11>2014 14:09 Oct 28, 2016 Jkt 241001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\31OCP1.SGM 31OCP1

Document Created: 2018-02-02 12:13:42
Document Modified: 2018-02-02 12:13:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule; extension of comment period.
Dates		FDA is extending the comment period on the proposed rule published August 24, 2016 (81 FR 58342). Submit either electronic or written comments by January 21, 2017.
Contact		Vernon Toelle, Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., MPN4-142, Rockville, MD 20855, 240- 402-5637; or Kristin Webster Maloney, Office of Policy and Risk Management, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4373, Silver Spring, MD 20993, 240-402-4993.
FR Citation		81 FR 75351
CFR Citation		21 CFR 16 21 CFR 58

81 FR 75351 - Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 210 (October 31, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration