[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Proposed Rules]
[Pages 42497-42499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19031]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. FDA-2017-N-5104]
Review of Existing Center for Veterinary Medicine Regulatory and
Information Collection Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for comments and information.
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SUMMARY: As part of the implementation of Executive Order 13771
entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and
Executive Order 13777 entitled, ``Enforcing the Regulatory Reform
Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is
seeking comments and information from interested parties to help FDA
identify existing regulations and related paperwork requirements that
could be modified, repealed, or replaced, consistent with the law, to
achieve meaningful burden reduction while allowing us to achieve our
public health mission and fulfill statutory obligations. This document
relates to the products regulated by the Center for Veterinary Medicine
(CVM).
DATES: Submit either electronic or written comments on this document by
December 7, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 7, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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, 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-2017-N-5104 for ``Review of Existing Center for Veterinary Medicine
Regulatory and Information Collection Requirements.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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.'' We will review
this copy, including the claimed confidential information, in our
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 Office, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5692, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. FDA's Regulatory Mission
FDA is responsible for protecting the public health by: (1)
Ensuring the safety, efficacy, and security of human and veterinary
drugs, biological products, and medical devices; (2) ensuring the
safety, security, and appropriate labeling of our nation's food supply,
products that emit radiation, and cosmetics; and (3) regulating the
manufacture, marketing, and distribution of tobacco products. Equally
important, FDA promotes the public health by fostering and supporting
innovative approaches and solutions for some of our nation's most
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compelling health and medical challenges.
FDA's CVM regulates the manufacture and distribution of food, food
additives, and drugs that will be given to animals, including animals
from which human foods are derived, as well as companion animals, and
takes enforcement action against unsafe veterinary devices. This
document is seeking comments and information solely on regulations and
approved information collections related to these product areas.
B. The Regulatory Reform Agenda: Executive Orders 13771 and 13777
On January 30, 2017, President Trump issued Executive Order 13771,
``Reducing Regulation and Controlling Regulatory Costs'' (Ref. 1). This
Executive Order states that the policy of the Executive Branch is to be
prudent and financially responsible in the expenditure of funds, from
both public and private sources, and that it is essential to manage the
costs associated with complying with Federal regulations. On February
24, 2017, President Trump issued Executive Order 13777, entitled
``Enforcing the Regulatory Reform Agenda'' (Ref. 2). The purpose of
this Executive Order is to alleviate unnecessary regulatory burdens
placed on the American people. Executive Order 13777 directs each
Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate
existing regulations and identify those that may merit repeal,
replacement, or modification. Section 3(d) of the Executive Order
provides that, at a minimum, each RRTF must attempt to identify
regulations that:
Eliminate jobs, or inhibit job creation;
Are outdated, unnecessary, or ineffective;
Impose costs that exceed benefits;
Create a serious inconsistency or otherwise interfere with
regulatory reform initiatives and policies;
Are inconsistent with the requirements of the Information
Quality Act, or the guidance issued pursuant to that Act, in particular
those regulations that rely in whole or in part on data, information,
or methods that are not publicly available or that are insufficiently
transparent to meet the standard for reproducibility; or
Derive from or implement Executive Orders or other
Presidential directives that have been subsequently rescinded or
substantially modified.
II. Request for Comments and Information
To assist with our implementation of Executive Orders 13771 and
13777 and support the work of the RRTF of the Department of Health and
Human Services, FDA is issuing this Request for Information soliciting
broad public comment on ways we can change our regulations to achieve
meaningful burden reduction while continuing to achieve our public
health mission and fulfill statutory obligations. We request comment,
including supporting technical, scientific, economic, or other data,
from all persons and entities significantly affected by FDA
regulations, including consumers, patients and caregivers, researchers,
health care institutions, the regulated industry, trade associations,
public interest organizations, academia, and State, local, and tribal
governments, as well as any other interested stakeholder. These
comments and data will supplement and inform our own ongoing,
systematic review of our regulations.
The following list of questions includes those that FDA is using to
guide our initial review of our regulations. This list is intended to
help the public in providing comments, not to restrict the issues that
may be addressed.
Is the regulation still current, or is it outdated or
unnecessary in some way?
[cir] Have there been advancements and innovations in science,
technology, or FDA or industry practice, or any other changes that
suggest repeal of or modification to the regulation may be warranted or
appropriate?
[cir] Has the regulation been superseded or made irrelevant or
unenforceable by statute, another FDA regulation or guidance, a
regulation by another Federal Agency, or controlling legal authority?
If yes, identify the statute, regulation, guidance, or legal precedent
and explain what FDA regulation is affected and in what way it is
affected.
[cir] Is this regulation duplicative of requirements in other FDA
regulations or other Federal Agency regulations? If yes, identify the
overlapping regulation(s) and responsible Federal Agency and describe
the way(s) in which the regulations overlap, as well as any suggestions
with respect to how best to resolve the duplication.
Have regulated entities had difficulties complying with
the regulation? If yes, identify what entity or entities have had such
difficulties and the nature of the difficulties.
Does the regulation impose requirements that are also
provided for in voluntary or consensus standards or guidance by third
party organizations (e.g., International Council for Harmonisation,
International Organization for Standardization, Codex Alimentarius)? Do
the entities covered by these standards or guidance take steps to meet
the standards and to document that they meet the standards? If met, do
the standards achieve the same level of public health protection as the
FDA regulation? Are there entities who are not covered by these
standards or guidances or who choose not to observe them?
Does the regulation contain redundant, outdated, or
unnecessary collections of information or retention of records, e.g.,
reporting, recordkeeping, or labeling requirements? Explain in your
response why the information is redundant, outdated, or unnecessary.
Could the goal of the regulation be achieved by less
costly means that would provide the same level of public health
protection? If yes, provide examples of alternatives that may reduce
costs to industry while retaining the same level of public health
protection.
What factors should FDA consider in selecting and
prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at https://www.ecfr.gov. We request that comments be as specific as possible,
include any supporting data or other information, such as cost
information, provide a Code of Federal Regulations (CFR) citation when
referencing a specific regulation, and provide specific suggestions
regarding repeal, replacement, or modification. For comments relating
to an information collection, cite to the approved information
collection request and include the Office of Management and Budget
(OMB) control number.
In addition, in order to enable us to more efficiently review and
consider comments, we ask that the comments be submitted in the format
shown in table 1 of this document.
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Table 1--Format for Submitting Comments
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Name of regulation
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Type of product or FDA Center
regulating the product.
Citation to Code of Federal Regulations
and statutory citation (as
applicable).
Approved information collection and OMB
Control Number (as applicable).
Brief description of concern........... (For example, what innovation
makes the regulation outdated?
Why?)
Available data on cost or economic (Quantified costs and/or cost
impact. savings. Qualitative
description, if needed.)
Proposed solution...................... (Include your solution. For
example, how would you modify
the regulation? Provide
specific text if you are
recommending a modification.)
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III. References
The following references are on display in the Dockets Management
Staff Office (see ADDRESSES) and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
1. Executive Order 13771 (January 30, 2017); available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs.
2. Executive Order 13777 (February 24, 2017); available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.
Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19031 Filed 9-7-17; 8:45 am]
BILLING CODE 4164-01-P