Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final Rule, 3631-3635 [2018-01467]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules
labor rate of $85 per hour, replacing a
tube assembly would require about 6
work-hours and required parts would
cost $4,902, for a total cost of $5,412 per
helicopter and $1,353,000 for the U.S.
fleet.
According to Bell’s service
information, some of the costs of this
proposed AD may be covered under
warranty, thereby reducing the cost
impact on affected individuals. We do
not control warranty coverage by Bell.
Accordingly, we have included all costs
in our cost estimate.
Authority for This Rulemaking
Title 49 of the United States Code
specifies the FAA’s authority to issue
rules on aviation safety. Subtitle I,
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII:
Aviation Programs,’’ describes in more
detail the scope of the Agency’s
authority.
We are issuing this rulemaking under
the authority described in ‘‘Subtitle VII,
Part A, Subpart III, Section 44701:
General requirements.’’ Under that
section, Congress charges the FAA with
promoting safe flight of civil aircraft in
air commerce by prescribing regulations
for practices, methods, and procedures
the Administrator finds necessary for
safety in air commerce. This regulation
is within the scope of that authority
because it addresses an unsafe condition
that is likely to exist or develop on
products identified in this rulemaking
action.
daltland on DSKBBV9HB2PROD with PROPOSALS
Regulatory Findings
We determined that this proposed AD
would not have federalism implications
under Executive Order 13132. This
proposed AD would not have a
substantial direct effect on the States, on
the relationship between the national
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.
For the reasons discussed, I certify
this proposed regulation:
1. Is not a ‘‘significant regulatory
action’’ under Executive Order 12866;
2. Is not a ‘‘significant rule’’ under the
DOT Regulatory Policies and Procedures
(44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in
Alaska to the extent that it justifies
making a regulatory distinction; and
4. Will not have a significant
economic impact, positive or negative,
on a substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
We prepared an economic evaluation
of the estimated costs to comply with
VerDate Sep<11>2014
19:24 Jan 25, 2018
Jkt 244001
this proposed AD and placed it in the
AD docket.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by Reference,
Safety.
The Proposed Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA proposes to amend 14 CFR part
39 as follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive (AD):
■
Bell Helicopter Textron Inc.: Docket No.
FAA–2018–0036; Product Identifier
2017–SW–015–AD.
(a) Applicability
This AD applies to Bell Helicopter Textron
Inc. (Bell) Model 212, Model 412, and Model
412EP helicopters, certificated in any
category, with an emergency flotation system
(EFS) tube assembly part number (P/N) 412–
073–820–101 with a date of manufacture
before July 28, 2016, or an unknown date of
manufacture installed.
(b) Unsafe Condition
This AD defines the unsafe condition as a
crack on an EFS tube assembly. This
condition could result in failure of the
emergency floats to inflate during an
emergency water landing.
(c) Comments Due Date
We must receive comments by March 27,
2018.
(d) Compliance
You are responsible for performing each
action required by this AD within the
specified compliance time unless it has
already been accomplished prior to that time.
(e) Required Actions
(1) Within 300 hours time-in-service:
(i) Remove the EFS tube assembly from
service.
(ii) Lubricate the shoulder of the sleeves,
threads, and seat of each mating fitting with
anti-seize compound.
(iii) Install an EFS tube assembly not listed
in paragraph (a) of this AD.
(2) After the effective date of this AD, do
not install an EFS tube assembly listed in
paragraph (a) of this AD on any helicopter.
(f) Alternative Methods of Compliance
(AMOC)
(1) The Manager, DSCO Branch, FAA, may
approve AMOCs for this AD. Send your
proposal to: Rory Rieger, Aviation Safety
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
3631
Engineer, DSCO Branch, AIR–7J0, FAA,
10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone (817) 222–5193; email
rory.rieger@faa.gov.
(2) For operations conducted under a 14
CFR part 119 operating certificate or under
14 CFR part 91, subpart K, we suggest that
you notify your principal inspector, or
lacking a principal inspector, the manager of
the local flight standards district office or
certificate holding district office before
operating any aircraft complying with this
AD through an AMOC.
(g) Additional Information
Bell Helicopter Alert Service Bulletins
212–11–143 and 412–11–147, both Revision
C and dated December 22, 2016, which are
not incorporated by reference, contain
additional information about the subject of
this AD. For service information identified in
this proposed rule, contact Bell Helicopter
Textron, Inc., P.O. Box 482, Fort Worth, TX
76101; telephone (817) 280–3391; fax (817)
280–6466; or at https://
www.bellcustomer.com/files/. You may
review a copy of information at the FAA,
Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N–
321, Fort Worth, TX 76177.
(h) Subject
Joint Aircraft Service Component (JASC)
Code: 3212 Emergency Flotation Section.
Issued in Fort Worth, Texas, on January 12,
2018.
Scott A. Horn,
Deputy Director for Regulatory Operations,
Compliance & Airworthiness Division,
Aircraft Certification Service.
[FR Doc. 2018–01195 Filed 1–25–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. FDA–2017–N–7007]
RIN 0910–AH49
Removal of Certain Time of Inspection
and Duties of Inspector Regulations
for Biological Products; Companion to
Direct Final Rule
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA, Agency, or we) is
proposing to amend the general
biologics regulations relating to time of
inspection requirements and also
removing duties of inspector
requirements. FDA is proposing this
action to remove outdated requirements
and accommodate new approaches,
SUMMARY:
E:\FR\FM\26JAP1.SGM
26JAP1
3632
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules
daltland on DSKBBV9HB2PROD with PROPOSALS
such as a risk-based inspection
frequency for drug establishments,
thereby providing flexibility without
diminishing public health protections.
This action is part of FDA’s
implementation of Executive Orders
(EOs) 13771 and 13777. Under these
EOs, FDA is comprehensively reviewing
existing regulations to identify
opportunities for repeal, replacement, or
modification that will result in
meaningful burden reduction while
allowing the Agency to achieve our
public health mission and fulfill
statutory obligations.
DATES: Submit either electronic or
written comments on the proposed rule
or its companion direct final rule by
April 11, 2018. If FDA receives any
timely significant adverse comments on
the direct final rule with which this
proposed rule is associated, the Agency
will publish a document withdrawing
the direct final rule within 30 days after
the comment period ends. FDA will
apply any significant adverse comments
received on the direct final rule to the
proposed rule in developing the final
rule. FDA will then proceed to respond
to comments under this proposed rule
using the usual notice and comment
procedures.
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 April 11,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 11, 2018. 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
VerDate Sep<11>2014
19:24 Jan 25, 2018
Jkt 244001
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–7007 for ‘‘Removal of Certain
Time of Inspection and Duties of
Inspector Regulations for Biological
Products.’’ 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
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
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
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/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Melissa Segal, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is proposing to amend the
general biologics regulations relating to
time of inspection requirements and to
remove duties of inspector
requirements. FDA is proposing this
action to remove outdated requirements
and accommodate new approaches,
such as a risk-based inspection
frequency for drug establishments,
thereby providing flexibility without
diminishing public health protections.
B. Summary of the Major Provisions of
the Proposed Rule
This proposed rule would revise the
time of inspection requirements
contained in § 600.21 (21 CFR 600.21)
and also remove the duties of inspector
requirements contained in § 600.22 (21
CFR 600.22). These changes to the
biological product regulations would
eliminate outdated requirements and
accommodate new approaches, such as
a risk-based inspection frequency for
drug establishments, thereby providing
flexibility without diminishing public
health protections. Revision and
removal of these regulations would not
change the biological product
establishment inspection requirements
and duties of an investigator
requirements that apply under sections
704 and 510(h) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 374 and 360(h)) and section
351(c) of the Public Health Service Act
(PHS Act) (42 U.S.C. 262(c)).
E:\FR\FM\26JAP1.SGM
26JAP1
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules
C. Legal Authority
FDA is proposing this action under
the biological product provisions of the
PHS Act, and the drugs and general
administrative provisions of the FD&C
Act, including sections 704 and 510(h)
of the FD&C Act and section 351(c) of
the PHS Act.
D. Costs and Benefits
Because this proposed rule would not
impose any additional regulatory
burdens, this regulation is not
anticipated to result in any compliance
costs and the economic impact is
expected to be minimal.
daltland on DSKBBV9HB2PROD with PROPOSALS
II. Companion Document to Direct
Final Rulemaking
This proposed rule is a companion to
the direct final rule published in the
rules section of this issue of the Federal
Register. This companion proposed rule
provides the procedural framework to
finalize the rule in the event that the
direct final rule receives any significant
adverse comment and is withdrawn.
The comment period for this companion
proposed rule runs concurrently with
the comment period for the direct final
rule. Any comments received in
response to this companion proposed
rule will also be considered as
comments regarding the direct final
rule. FDA is publishing the direct final
rule because we believe the rule
contains noncontroversial changes and
there is little likelihood that there will
be significant adverse comments
opposing the rule.
A significant adverse comment is
defined as a comment that explains why
the rule would be inappropriate,
including challenges to the rule’s
underlying premise or approach, or
would be ineffective or unacceptable
without a change. In determining
whether an adverse comment is
significant and warrants terminating a
direct final rulemaking, we will
consider whether the comment raises an
issue serious enough to warrant a
substantive response in a notice-andcomment process. Comments that are
frivolous, insubstantial, or outside the
scope of the rule will not be considered
significant or adverse under this
procedure. A comment recommending a
regulation change in addition to those in
the direct final rule would not be
considered a significant adverse
comment unless the comment states
why the rule would be ineffective
without the additional change. In
addition, if a significant adverse
comment applies to a part of the direct
final rule and that part can be severed
from the remainder of the rule, we may
VerDate Sep<11>2014
19:24 Jan 25, 2018
Jkt 244001
adopt as final those provisions of the
rule that are not the subject of the
significant adverse comment.
If any significant adverse comments to
the direct final rule are received during
the comment period, FDA will publish,
within 30 days after the comment
period ends, a notice of significant
adverse comment and withdraw the
direct final rule. If we withdraw the
direct final rule, any comments received
will be considered comments on the
proposed rule and will be considered in
developing a final rule using the usual
notice-and-comment procedure.
If no significant adverse comment is
received in response to the direct final
rule during the comment period, no
further action will be taken related to
this proposed rule. Instead, we will
publish a document confirming the
effective date within 30 days after the
comment period ends. Additional
information about direct final
rulemaking procedures is set forth in the
document entitled ‘‘Guidance for FDA
and Industry: Direct Final Rule
Procedures,’’ announced and provided
in the Federal Register of November 21,
1997 (62 FR 62466). The guidance may
be accessed at: https://www.fda.gov/
RegulatoryInformation/Guidances/
ucm125166.htm.
III. Background
On February 24, 2017, President
Donald Trump issued Executive Order
13777, ‘‘Enforcing the Regulatory
Reform Agenda’’ (82 FR 12285, March 1,
2017). One of the provisions in the
Executive Order requires Agencies to
evaluate existing regulations and make
recommendations to the Agency head
regarding their repeal, replacement, or
modification, consistent with applicable
law. As one step in implementing the
Executive Order, FDA published a
notice in the Federal Register of
September 8, 2017 (82 FR 42492)
entitled ‘‘Review of Existing Center for
Biologics Evaluation and Research
Regulatory and Information Collection
Requirements.’’ In that notice, FDA
announced that it was conducting a
review of existing regulations to
determine, in part, whether they can be
made more effective in light of current
public health needs and to take
advantage of, and support, advances in
innovation that have occurred since
those regulations took effect. As part of
this initiative, FDA is updating outdated
regulations as specified in this rule.
FDA’s general biological products
regulations in part 600 (21 CFR part
600) are intended to help ensure the
safety, purity, and potency of biological
products administered to humans. The
proposed revision and removal of
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
3633
certain general biological products
regulations are designed to eliminate
outdated requirements and
accommodate new approaches, such as
a risk-based inspection frequency for
drug establishments and provide
flexibility without diminishing public
health protections.
A. Section 600.21
The authority for FDA to conduct
establishment inspections is included in
both the FD&C Act and the PHS Act.
Specifically, section 704 of the FD&C
Act and section 351(c) of the PHS Act
authorize the Agency to inspect
establishments that manufacture
biological products. Before July 9,
2012—the date the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112–144) was
signed into law—section 510(h) of the
FD&C Act further provided, among
other things, that drug and device
establishments registered with FDA
must be inspected at least once in the
2-year period beginning with the date of
registration and at least once in every
successive 2-year period thereafter.
Section 510(h) of the FD&C Act applies
to biological product establishments
because all biological products are
subject to regulation under the drug or
device provisions of the FD&C Act (in
addition to the biological product
provisions of the PHS Act). Since 1983,
FDA’s biological product regulation at
§ 600.21 has also included a biennial
inspection requirement (‘‘[A]n
inspection of each licensed
establishment and its additional
location(s) shall be made at least once
every 2 years’’); this was consistent with
the pre-FDASIA biennial inspection
requirement in section 510(h) of the
FD&C Act.
With the enactment of FDASIA,
however, the biennial inspection
requirement for drug establishments in
section 510(h) of the FD&C Act was
replaced with a requirement that FDA
inspect drug establishments in
accordance with a risk-based schedule
established by FDA. Accordingly, for
biological product establishments that
are registered as drug establishments
under section 510(h), the requirement in
§ 600.21 regarding the frequency of
inspections is no longer consistent with
the FD&C Act and is outdated (e.g., the
risk-based inspection schedule for drug
establishments may result in scheduling
inspections at intervals of greater than 2
years for certain biological product
establishments). For this reason, and to
provide for greater flexibility in general
with respect to determining the
frequency of biological product
establishment inspections under the
E:\FR\FM\26JAP1.SGM
26JAP1
3634
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules
authority provided in the FD&C Act and
the PHS Act, FDA proposes to revise
§ 600.21 to remove the biennial
inspection requirement for biological
product establishments that are
registered as drug establishments and
for those that are registered as device
establishments.
In addition, § 600.21 includes
provisions concerning inspectional
notice and the timing of pre-licensure
reinspections of biological product
establishments. These provisions are
outdated and unnecessary. Inspectional
notice is addressed in the Agency’s
practices for inspections in its Standard
Operating Procedures and Policies and
in the Investigations Operations Manual
(IOM). With respect to the timing of a
reinspection of a biological product
establishment following the denial of a
biologics license application, the
general biologics licensing provision at
21 CFR 601.4, which was issued
subsequent to § 600.21, sets forth the
administrative procedures following the
denial of a license; accordingly, the
specific provision in § 600.21 regarding
timing of a reinspection following
denial of a license is unnecessary.
Therefore, FDA is proposing to remove
these provisions.
daltland on DSKBBV9HB2PROD with PROPOSALS
B. Section 600.22
Current § 600.22 requires specific
duties of an FDA inspector. These
existing codified requirements are
unnecessary because they are
duplicative of statutory requirements
that apply to biological product
inspections under section 704 of the
FD&C Act. Specifically, the inspection
requirements in section 704 of the FD&C
Act encompass all of the requirements
outlined in § 600.22. Thus, we are
proposing to remove § 600.22(a) through
(h).
The removal of these regulations,
however, would not change the
establishment inspection requirements
and duties of an investigator
requirements specified in sections 704
and 510(h) of the FD&C Act, section
351(c) of the PHS Act, or the procedures
described in the IOM. Additionally, it
would not change the established
process for risk-based inspection
planning and work planning.
IV. Highlights of the Proposed Rule
FDA is proposing to amend the
general biologics regulations by revising
time of inspection requirements
contained in § 600.21 and also by
removing the duties of inspector
requirements contained in § 600.22.
These proposed changes are designed to
remove the existing codified
requirements that are outdated and to
VerDate Sep<11>2014
19:24 Jan 25, 2018
Jkt 244001
accommodate new approaches, such as
a risk-based inspection frequency for
biological product establishments,
thereby providing flexibility without
diminishing public health protections.
V. Legal Authority
FDA is issuing this proposed rule
under the biological products provisions
of the PHS Act (42 U.S.C. 216, 262, 263,
263a, 264, and 300aa–25) and the drugs
and general administrative provisions of
the FD&C Act (21 U.S.C. 321, 351, 352,
353, 355, 356c, 356e, 360, 360i, 371,
374, and 379k–l). Under these
provisions of the PHS Act and the FD&C
Act, we have the authority to issue and
enforce regulations designed to ensure
that biological products are safe, pure,
and potent, and prevent the
introduction, transmission, and spread
of communicable disease.
VI. Economic Analysis of Impacts
We have examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563,
Executive Order 13771, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). Executive Order
13771 requires that the costs associated
with significant new regulations ‘‘shall,
to the extent permitted by law, be offset
by the elimination of existing costs
associated with at least two prior
regulations.’’ We believe that this
proposed rule is not a significant
regulatory action as defined by
Executive Order 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because the proposed rule does not
impose any additional regulatory
burdens, we propose to certify that the
proposed rule will not have a significant
economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $148 million,
using the most current (2016) Implicit
Price Deflator for the Gross Domestic
Product. This proposed rule would not
result in an expenditure in any year that
meets or exceeds this amount.
This proposed rule proposes
amendments to the general biologics
regulations by removing time of
inspection requirements and the duties
of inspector requirements. FDA is
proposing this action to remove
outdated requirements, accommodate
new approaches, and provide flexibility
without diminishing public health
protections. Because this rulemaking
proposes removal of regulations to be
consistent with updated practice and
does not impose any additional
regulatory burdens, this proposed
rulemaking is not anticipated to result
in any compliance costs and the
economic impact is expected to be
minimal.
VII. Analysis of Environmental Impact
We have determined under 21 CFR
25.31(h) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VIII. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have determined that this proposed rule
does not contain policies that have
substantial direct effects on the States,
on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the Executive
order and, consequently, a federalism
summary impact statement is not
required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
proposed rule contains no collection of
information. Therefore, clearance by the
Office of Management and Budget under
the Paperwork Reduction Act of 1995 is
not required.
List of Subjects in 21 CFR Part 600
Biologics, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
E:\FR\FM\26JAP1.SGM
26JAP1
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules
Health Service Act, and under authority
delegated to the Commissioner of Food
and Drugs, it is proposed that 21 CFR
part 600 be amended as follows:
PART 600—BIOLOGICAL PRODUCTS:
GENERAL
1. The authority citation for part 600
continues to read as follows:
■
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 356c, 356e, 360, 360i, 371, 374, 379k–
l; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa–
25.
§ 600.21
[Amended]
2. Amend § 600.21 by removing the
last three sentences.
■
§ 600.22
■
[Removed and Reserved]
3. Remove and reserve § 600.22.
Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01467 Filed 1–25–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Parts 3280, 3282, and 3285
[Docket No. FR–6075–N–01]
Regulatory Review of Manufactured
Housing Rules
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, Department of Housing
and Urban Development, HUD.
ACTION: Request for comments on
regulatory review.
AGENCY:
Consistent with Executive
Order 13771 entitled ‘‘Reducing
Regulation and Controlling Regulatory
Costs,’’ and Executive Order 13777
entitled, ‘‘Enforcing the Regulatory
Reform Agenda,’’ and as part of the
efforts of HUD’s Regulatory Reform Task
Force, this document informs the public
that HUD is reviewing its existing and
planned manufactured housing
regulatory actions to assess their actual
and potential compliance costs and
reduce regulatory burden. HUD invites
public comment to assist in identifying
regulations that may be outmoded,
ineffective or excessively burdensome
and should be modified, streamlined,
replaced or repealed.
DATES: Comment Due Date: February 26,
2018.
ADDRESSES: Interested persons are
invited to submit comments regarding
this notice to the Regulations Division,
Office of General Counsel, Department
daltland on DSKBBV9HB2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
19:24 Jan 25, 2018
Jkt 244001
of Housing and Urban Development,
451 7th Street SW, Room 10276,
Washington, DC 20410–0500.
Communications must refer to the above
docket number and title.
Electronic Submission of Comments.
Interested persons may submit
comments electronically through the
Federal eRulemaking Portal at
www.regulations.gov. HUD strongly
encourages commenters to submit
comments electronically. Electronic
submission of comments allows the
commenter maximum time to prepare
and submit a comment, ensures timely
receipt by HUD, and enables HUD to
make them immediately available to the
public. Comments submitted
electronically through the
www.regulations.gov website can be
viewed by other commenters and
interested members of the public.
Commenters should follow the
instructions provided on that site to
submit comments electronically.
Note: To receive consideration as
public comments, comments must be
submitted through one of the two
methods specified above. Again, all
submissions must refer to the docket
number and title of the notice.
No Facsimile Comments. Facsimile
(fax) comments are not acceptable.
Public Inspection of Public
Comments. All properly submitted
comments and communications
submitted to HUD will be available for
public inspection and copying between
8 a.m. and 5 p.m. weekdays at the above
address. Due to security measures at the
HUD Headquarters building, an
appointment to review the public
comments must be scheduled in
advance by calling the Regulations
Division at 202–708–3055 (this is not a
toll-free number). Individuals with
speech or hearing impairments may
access this number via TTY by calling
the Federal Relay Service at 1–800–877–
8339 (this is a toll-free number). Copies
of all comments submitted are available
for inspection and downloading at
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Ariel Pereira, Associate General Counsel
for Legislation and Regulations, Office
of General Counsel, Department of
Housing and Urban Development, 451
7th Street SW, Room 10282, Washington
DC 20410; telephone number 202–402–
5138 (this is not a toll-free number).
Persons with hearing or speech
impairments may access this number
through TTY by calling the toll-free
Federal Relay Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
3635
I. Executive Orders 13771 and 13777
Under the leadership of Secretary
Carson, HUD has undertaken an effort,
consistent with Executive Order 13771
(82 FR 9339), entitled ‘‘Reducing
Regulation and Controlling Regulatory
Costs,’’ to identify and eliminate or
streamline regulations that are wasteful,
inefficient or unnecessary. Executive
Order 13771 requires that agencies
manage the costs associated with the
governmental imposition of private
expenditures required to comply with
Federal regulations. Toward this end,
Executive Order 13771 directs that for
each new regulation issued, at least two
prior regulations be identified for
elimination and requires that the cost of
planned regulations be prudently
managed and controlled. In furtherance
of this objective, the Secretary has also
led HUD’s implementation of Executive
Order 13777 (82 FR 12285), entitled
‘‘Enforcing the Regulatory Reform
Agenda.’’ Executive Order 13777
reaffirms the rulemaking principles of
Executive Order 13771 by directing each
agency to establish a Regulatory Reform
Task Force to evaluate existing
regulations to identify those that merit
repeal, replacement, modification, are
outdated, unnecessary, or are
ineffective, eliminate or inhibit job
creation, impose costs that exceed
benefits, or derive from or implement
Executive Orders that have been
rescinded or significantly modified.
II. This Notice
Manufactured housing plays a vital
role in meeting the nation’s affordable
housing needs, providing 9.5 percent of
the total single-family housing stock.1
According to the Manufactured Housing
Institute,2 more than 22 million
Americans reside in manufactured
housing. Manufactured homes are
particularly important in rural states,
where manufactured homes are
approximately 16.2 percent of occupied
housing units. The manufactured
housing industry is also an important
economic engine, accounting for
approximately 35,000 jobs nationwide.
HUD regulation of manufactured
housing fulfills a critical role of both
protecting consumers and ensuring a
fair and efficient market. HUD may
adopt, revise, and interpret HUD’s
manufactured housing program
regulations based on recommendations
of the Manufactured Housing Consensus
1 American
Housing Survey, 2013. Available at:
https://factfinder2.census.gov/faces/tableservices/
jsf/pages/productview.xhtml?pid=AHS_2013_
C01AH&prodType=table.
2 https://www.manufacturedhousing.org/researchand-data/.
E:\FR\FM\26JAP1.SGM
26JAP1
]]>Agencies
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Proposed Rules]
[Pages 3631-3635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01467]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. FDA-2017-N-7007]
RIN 0910-AH49
Removal of Certain Time of Inspection and Duties of Inspector
Regulations for Biological Products; Companion to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
proposing to amend the general biologics regulations relating to time
of inspection requirements and also removing duties of inspector
requirements. FDA is proposing this action to remove outdated
requirements and accommodate new approaches,
[[Page 3632]]
such as a risk-based inspection frequency for drug establishments,
thereby providing flexibility without diminishing public health
protections. This action is part of FDA's implementation of Executive
Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively
reviewing existing regulations to identify opportunities for repeal,
replacement, or modification that will result in meaningful burden
reduction while allowing the Agency to achieve our public health
mission and fulfill statutory obligations.
DATES: Submit either electronic or written comments on the proposed
rule or its companion direct final rule by April 11, 2018. If FDA
receives any timely significant adverse comments on the direct final
rule with which this proposed rule is associated, the Agency will
publish a document withdrawing the direct final rule within 30 days
after the comment period ends. FDA will apply any significant adverse
comments received on the direct final rule to the proposed rule in
developing the final rule. FDA will then proceed to respond to comments
under this proposed rule using the usual notice and comment procedures.
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 April 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 11, 2018. 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-7007 for ``Removal of Certain Time of Inspection and Duties
of Inspector Regulations for Biological Products.'' 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 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.
FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is proposing to amend the general biologics regulations
relating to time of inspection requirements and to remove duties of
inspector requirements. FDA is proposing this action to remove outdated
requirements and accommodate new approaches, such as a risk-based
inspection frequency for drug establishments, thereby providing
flexibility without diminishing public health protections.
B. Summary of the Major Provisions of the Proposed Rule
This proposed rule would revise the time of inspection requirements
contained in Sec. 600.21 (21 CFR 600.21) and also remove the duties of
inspector requirements contained in Sec. 600.22 (21 CFR 600.22). These
changes to the biological product regulations would eliminate outdated
requirements and accommodate new approaches, such as a risk-based
inspection frequency for drug establishments, thereby providing
flexibility without diminishing public health protections. Revision and
removal of these regulations would not change the biological product
establishment inspection requirements and duties of an investigator
requirements that apply under sections 704 and 510(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 374 and 360(h)) and
section 351(c) of the Public Health Service Act (PHS Act) (42 U.S.C.
262(c)).
[[Page 3633]]
C. Legal Authority
FDA is proposing this action under the biological product
provisions of the PHS Act, and the drugs and general administrative
provisions of the FD&C Act, including sections 704 and 510(h) of the
FD&C Act and section 351(c) of the PHS Act.
D. Costs and Benefits
Because this proposed rule would not impose any additional
regulatory burdens, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.
II. Companion Document to Direct Final Rulemaking
This proposed rule is a companion to the direct final rule
published in the rules section of this issue of the Federal Register.
This companion proposed rule provides the procedural framework to
finalize the rule in the event that the direct final rule receives any
significant adverse comment and is withdrawn. The comment period for
this companion proposed rule runs concurrently with the comment period
for the direct final rule. Any comments received in response to this
companion proposed rule will also be considered as comments regarding
the direct final rule. FDA is publishing the direct final rule because
we believe the rule contains noncontroversial changes and there is
little likelihood that there will be significant adverse comments
opposing the rule.
A significant adverse comment is defined as a comment that explains
why the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without a change. In determining whether an adverse comment is
significant and warrants terminating a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process. Comments that
are frivolous, insubstantial, or outside the scope of the rule will not
be considered significant or adverse under this procedure. A comment
recommending a regulation change in addition to those in the direct
final rule would not be considered a significant adverse comment unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to a part of the direct final rule and that part can be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of the significant adverse
comment.
If any significant adverse comments to the direct final rule are
received during the comment period, FDA will publish, within 30 days
after the comment period ends, a notice of significant adverse comment
and withdraw the direct final rule. If we withdraw the direct final
rule, any comments received will be considered comments on the proposed
rule and will be considered in developing a final rule using the usual
notice-and-comment procedure.
If no significant adverse comment is received in response to the
direct final rule during the comment period, no further action will be
taken related to this proposed rule. Instead, we will publish a
document confirming the effective date within 30 days after the comment
period ends. Additional information about direct final rulemaking
procedures is set forth in the document entitled ``Guidance for FDA and
Industry: Direct Final Rule Procedures,'' announced and provided in the
Federal Register of November 21, 1997 (62 FR 62466). The guidance may
be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.
III. Background
On February 24, 2017, President Donald Trump issued Executive Order
13777, ``Enforcing the Regulatory Reform Agenda'' (82 FR 12285, March
1, 2017). One of the provisions in the Executive Order requires
Agencies to evaluate existing regulations and make recommendations to
the Agency head regarding their repeal, replacement, or modification,
consistent with applicable law. As one step in implementing the
Executive Order, FDA published a notice in the Federal Register of
September 8, 2017 (82 FR 42492) entitled ``Review of Existing Center
for Biologics Evaluation and Research Regulatory and Information
Collection Requirements.'' In that notice, FDA announced that it was
conducting a review of existing regulations to determine, in part,
whether they can be made more effective in light of current public
health needs and to take advantage of, and support, advances in
innovation that have occurred since those regulations took effect. As
part of this initiative, FDA is updating outdated regulations as
specified in this rule.
FDA's general biological products regulations in part 600 (21 CFR
part 600) are intended to help ensure the safety, purity, and potency
of biological products administered to humans. The proposed revision
and removal of certain general biological products regulations are
designed to eliminate outdated requirements and accommodate new
approaches, such as a risk-based inspection frequency for drug
establishments and provide flexibility without diminishing public
health protections.
A. Section 600.21
The authority for FDA to conduct establishment inspections is
included in both the FD&C Act and the PHS Act. Specifically, section
704 of the FD&C Act and section 351(c) of the PHS Act authorize the
Agency to inspect establishments that manufacture biological products.
Before July 9, 2012--the date the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144) was signed into law--
section 510(h) of the FD&C Act further provided, among other things,
that drug and device establishments registered with FDA must be
inspected at least once in the 2-year period beginning with the date of
registration and at least once in every successive 2-year period
thereafter. Section 510(h) of the FD&C Act applies to biological
product establishments because all biological products are subject to
regulation under the drug or device provisions of the FD&C Act (in
addition to the biological product provisions of the PHS Act). Since
1983, FDA's biological product regulation at Sec. 600.21 has also
included a biennial inspection requirement (``[A]n inspection of each
licensed establishment and its additional location(s) shall be made at
least once every 2 years''); this was consistent with the pre-FDASIA
biennial inspection requirement in section 510(h) of the FD&C Act.
With the enactment of FDASIA, however, the biennial inspection
requirement for drug establishments in section 510(h) of the FD&C Act
was replaced with a requirement that FDA inspect drug establishments in
accordance with a risk-based schedule established by FDA. Accordingly,
for biological product establishments that are registered as drug
establishments under section 510(h), the requirement in Sec. 600.21
regarding the frequency of inspections is no longer consistent with the
FD&C Act and is outdated (e.g., the risk-based inspection schedule for
drug establishments may result in scheduling inspections at intervals
of greater than 2 years for certain biological product establishments).
For this reason, and to provide for greater flexibility in general with
respect to determining the frequency of biological product
establishment inspections under the
[[Page 3634]]
authority provided in the FD&C Act and the PHS Act, FDA proposes to
revise Sec. 600.21 to remove the biennial inspection requirement for
biological product establishments that are registered as drug
establishments and for those that are registered as device
establishments.
In addition, Sec. 600.21 includes provisions concerning
inspectional notice and the timing of pre-licensure reinspections of
biological product establishments. These provisions are outdated and
unnecessary. Inspectional notice is addressed in the Agency's practices
for inspections in its Standard Operating Procedures and Policies and
in the Investigations Operations Manual (IOM). With respect to the
timing of a reinspection of a biological product establishment
following the denial of a biologics license application, the general
biologics licensing provision at 21 CFR 601.4, which was issued
subsequent to Sec. 600.21, sets forth the administrative procedures
following the denial of a license; accordingly, the specific provision
in Sec. 600.21 regarding timing of a reinspection following denial of
a license is unnecessary. Therefore, FDA is proposing to remove these
provisions.
B. Section 600.22
Current Sec. 600.22 requires specific duties of an FDA inspector.
These existing codified requirements are unnecessary because they are
duplicative of statutory requirements that apply to biological product
inspections under section 704 of the FD&C Act. Specifically, the
inspection requirements in section 704 of the FD&C Act encompass all of
the requirements outlined in Sec. 600.22. Thus, we are proposing to
remove Sec. 600.22(a) through (h).
The removal of these regulations, however, would not change the
establishment inspection requirements and duties of an investigator
requirements specified in sections 704 and 510(h) of the FD&C Act,
section 351(c) of the PHS Act, or the procedures described in the IOM.
Additionally, it would not change the established process for risk-
based inspection planning and work planning.
IV. Highlights of the Proposed Rule
FDA is proposing to amend the general biologics regulations by
revising time of inspection requirements contained in Sec. 600.21 and
also by removing the duties of inspector requirements contained in
Sec. 600.22. These proposed changes are designed to remove the
existing codified requirements that are outdated and to accommodate new
approaches, such as a risk-based inspection frequency for biological
product establishments, thereby providing flexibility without
diminishing public health protections.
V. Legal Authority
FDA is issuing this proposed rule under the biological products
provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, 264, and
300aa-25) and the drugs and general administrative provisions of the
FD&C Act (21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i,
371, 374, and 379k-l). Under these provisions of the PHS Act and the
FD&C Act, we have the authority to issue and enforce regulations
designed to ensure that biological products are safe, pure, and potent,
and prevent the introduction, transmission, and spread of communicable
disease.
VI. Economic Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule does not impose any additional
regulatory burdens, we propose to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
This proposed rule proposes amendments to the general biologics
regulations by removing time of inspection requirements and the duties
of inspector requirements. FDA is proposing this action to remove
outdated requirements, accommodate new approaches, and provide
flexibility without diminishing public health protections. Because this
rulemaking proposes removal of regulations to be consistent with
updated practice and does not impose any additional regulatory burdens,
this proposed rulemaking is not anticipated to result in any compliance
costs and the economic impact is expected to be minimal.
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.31(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.
IX. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
List of Subjects in 21 CFR Part 600
Biologics, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public
[[Page 3635]]
Health Service Act, and under authority delegated to the Commissioner
of Food and Drugs, it is proposed that 21 CFR part 600 be amended as
follows:
PART 600--BIOLOGICAL PRODUCTS: GENERAL
0
1. The authority citation for part 600 continues to read as follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360,
360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa-
25.
Sec. 600.21 [Amended]
0
2. Amend Sec. 600.21 by removing the last three sentences.
Sec. 600.22 [Removed and Reserved]
0
3. Remove and reserve Sec. 600.22.
Dated: January 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01467 Filed 1-25-18; 8:45 am]
BILLING CODE 4164-01-P
