83 FR 3586 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

Page Range		3586-3589
FR Document		2018-01468

The Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without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. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, 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. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.

Federal Register, Volume 83 Issue 18 (Friday, January 26, 2018)

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3586-3589]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01468]

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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
amending the general biologics regulations relating to time of
inspection requirements and also removing duties of inspector
requirements. FDA is taking this action to remove outdated requirements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. This action is part of
FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under
these E.O.s, 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.
The Agency is issuing these amendments directly as a final rule because
we believe they are noncontroversial and FDA anticipates no significant
adverse comments.

DATES: This rule is effective June 11, 2018. Submit either electronic
or written comments on the direct final rule or its companion proposed
rule by April 11, 2018. If FDA receives no significant adverse comments
within the specified comment period, the Agency intends to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If timely significant adverse comments are received, the
Agency will publish a document in the Federal Register withdrawing this
direct final rule within 30 days after the comment period on this
direct final rule ends.

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

[[Page 3587]]

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.thefederalregister.org/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 Direct Final Rule

FDA is issuing this direct final rule to amend the general
biologics regulations relating to time of inspection requirements and
to remove duties of inspector requirements. FDA is taking 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 Direct Final Rule

This direct final rule revises the time of inspection requirements
contained in Sec. 600.21 (21 CFR 600.21) and also removes the duties
of inspector requirements contained in Sec. 600.22 (21 CFR 600.22).
These changes to the biological product regulations 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 does 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)).

C. Legal Authority

FDA is taking 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 direct final rule does 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. Direct Final Rulemaking

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), FDA described its procedures on
when and how the Agency will employ direct final rulemaking. The
guidance may be accessed at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm. We have determined that this rule is
appropriate for direct final rulemaking because we believe that it
includes only noncontroversial amendments and we anticipate no
significant adverse comments. Consistent with our procedures on direct
final rulemaking, FDA is also publishing elsewhere in this issue of the
Federal Register a companion proposed rule proposing to amend the
general biological products regulations by removing certain time of
inspection requirements and the duties of inspector requirements. The
companion proposed rule provides a procedural framework within which
the rule may be finalized in the event that the direct final rule is
withdrawn because of any significant adverse comments. The comment
period for the direct final rule runs concurrently with the companion
proposed rule. Any comments received in response to the companion
proposed rule will be considered as comments regarding the direct final
rule.
We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comments, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register. 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 this 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 are received during the comment
period, FDA will publish, before the effective date of this direct
final rule, a notice of significant adverse comment and withdraw the
direct final rule. If we withdraw the direct final rule, any comments
received will be applied to the proposed rule and will be considered in
developing a final rule using the usual notice-and-comment procedure.
If FDA receives no significant adverse comments during the
specified

[[Page 3588]]

comment period, FDA intends to publish a document confirming the
effective date within 30 days after the comment period ends.

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 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 authority provided in the FD&C Act
and the PHS Act, FDA is revising 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 removing 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 removing Sec.
600.22(a) through (h).
The removal of these regulations, however, does 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 does not change the established process for risk-based
inspection planning and work planning.

IV. Highlights of the Direct Final Rule

FDA is revising 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 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. FDA is issuing these revisions directly as a
final rule because the Agency believes they include only
noncontroversial amendments and FDA anticipates no significant adverse
comments.

V. Legal Authority

FDA is issuing this 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 direct final rule under
Executive Order

[[Page 3589]]

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 direct final 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 direct final rule does not impose any additional
regulatory burdens, we certify that this direct final 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 issuing ``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 direct final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This rule is being issued to amend the general biologics
regulations by removing time of inspection requirements and the duties
of inspector requirements. This action is being taken to remove
outdated requirements, accommodate new approaches, and provide
flexibility without diminishing public health protections. Because this
rulemaking would remove regulations to be consistent with updated
practice and does not impose any additional regulatory burdens, this
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 direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the 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

This direct final 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 Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 600 is 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. 2018-01468 Filed 1-25-18; 8:45 am]
BILLING CODE 4164-01-P

3588 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations

comment period, FDA intends to Section 510(h) of the FD&C Act applies Therefore, FDA is removing these
publish a document confirming the to biological product establishments provisions.
effective date within 30 days after the because all biological products are
B. Section 600.22
comment period ends. subject to regulation under the drug or
device provisions of the FD&C Act (in Current § 600.22 requires specific
III. Background duties of an FDA inspector. These
addition to the biological product
On February 24, 2017, President provisions of the PHS Act). Since 1983, existing codified requirements are
Donald Trump issued Executive Order FDA’s biological product regulation at unnecessary because they are
13777, ‘‘Enforcing the Regulatory § 600.21 has also included a biennial duplicative of statutory requirements
Reform Agenda’’ (82 FR 12285, March 1, inspection requirement (‘‘[A]n that apply to biological product
2017). One of the provisions in the inspection of each licensed inspections under section 704 of the
Executive Order requires Agencies to establishment and its additional FD&C Act. Specifically, the inspection
evaluate existing regulations and make location(s) shall be made at least once requirements in section 704 of the FD&C
recommendations to the Agency head every 2 years’’); this was consistent with Act encompass all of the requirements
regarding their repeal, replacement, or the pre-FDASIA biennial inspection outlined in § 600.22. Thus, we are
modification, consistent with applicable requirement in section 510(h) of the removing § 600.22(a) through (h).
law. As one step in implementing the FD&C Act. The removal of these regulations,
Executive Order, FDA published a With the enactment of FDASIA, however, does not change the
notice in the Federal Register of however, the biennial inspection establishment inspection requirements
September 8, 2017 (82 FR 42492) requirement for drug establishments in and duties of an investigator
entitled ‘‘Review of Existing Center for section 510(h) of the FD&C Act was requirements specified in sections 704
Biologics Evaluation and Research replaced with a requirement that FDA and 510(h) of the FD&C Act, section
Regulatory and Information Collection inspect drug establishments in 351(c) of the PHS Act, or the procedures
Requirements.’’ In that notice, FDA accordance with a risk-based schedule described in the IOM. Additionally, it
announced that it was conducting a established by FDA. Accordingly, for does not change the established process
review of existing regulations to biological product establishments that for risk-based inspection planning and
determine, in part, whether they can be are registered as drug establishments work planning.
made more effective in light of current under section 510(h), the requirement in
public health needs and to take § 600.21 regarding the frequency of IV. Highlights of the Direct Final Rule
advantage of, and support, advances in inspections is no longer consistent with FDA is revising the general biologics
innovation that have occurred since the FD&C Act and is outdated (e.g., the regulations by revising time of
those regulations took effect. As part of risk-based inspection schedule for drug inspection requirements contained in
this initiative, FDA is updating outdated establishments may result in scheduling § 600.21 and also by removing the
regulations as specified in this rule. inspections at intervals of greater than 2 duties of inspector requirements
FDA’s general biological products years for certain biological product contained in § 600.22. These changes
regulations in part 600 (21 CFR part establishments). For this reason, and to are designed to remove the existing
600) are intended to help ensure the provide for greater flexibility in general codified requirements that are outdated
safety, purity, and potency of biological with respect to determining the and to accommodate new approaches,
products administered to humans. The frequency of biological product such as a risk-based inspection
revision and removal of certain general establishment inspections under the frequency for biological product
biological products regulations are authority provided in the FD&C Act and establishments, thereby providing
designed to eliminate outdated the PHS Act, FDA is revising § 600.21 to flexibility without diminishing public
requirements and accommodate new remove the biennial inspection health protections. FDA is issuing these
approaches, such as a risk-based requirement for biological product revisions directly as a final rule because
inspection frequency for drug establishments that are registered as the Agency believes they include only
establishments and provide flexibility drug establishments and for those that noncontroversial amendments and FDA
without diminishing public health are registered as device establishments. anticipates no significant adverse
protections. In addition, § 600.21 includes comments.
provisions concerning inspectional
A. Section 600.21 V. Legal Authority
notice and the timing of pre-licensure
The authority for FDA to conduct reinspections of biological product FDA is issuing this rule under the
establishment inspections is included in establishments. These provisions are biological products provisions of the
both the FD&C Act and the PHS Act. outdated and unnecessary. Inspectional PHS Act (42 U.S.C. 216, 262, 263, 263a,
Specifically, section 704 of the FD&C notice is addressed in the Agency’s 264, and 300aa–25) and the drugs and
Act and section 351(c) of the PHS Act practices for inspections in its Standard general administrative provisions of the
authorize the Agency to inspect Operating Procedures and Policies and FD&C Act (21 U.S.C. 321, 351, 352, 353,
establishments that manufacture in the Investigations Operations Manual 355, 356c, 356e, 360, 360i, 371, 374, and
biological products. Before July 9, (IOM). With respect to the timing of a 379k–l). Under these provisions of the
2012—the date the Food and Drug reinspection of a biological product PHS Act and the FD&C Act, we have the
Administration Safety and Innovation establishment following the denial of a authority to issue and enforce
Act (FDASIA) (Pub. L. 112–144) was biologics license application, the regulations designed to ensure that
signed into law—section 510(h) of the general biologics licensing provision at biological products are safe, pure, and
FD&C Act further provided, among
daltland on DSKBBV9HB2PROD with RULES

21 CFR 601.4, which was issued potent, and prevent the introduction,
other things, that drug and device subsequent to § 600.21, sets forth the transmission, and spread of
establishments registered with FDA administrative procedures following the communicable disease.
must be inspected at least once in the denial of a license; accordingly, the
2-year period beginning with the date of specific provision in § 600.21 regarding VI. Economic Analysis of Impacts
registration and at least once in every timing of a reinspection following We have examined the impacts of the
successive 2-year period thereafter. denial of a license is unnecessary. direct final rule under Executive Order

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Document Created: 2018-10-26 10:07:21
Document Modified: 2018-10-26 10:07:21

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		Rules and Regulations
Action		Direct final rule.
Dates		This rule is effective June 11, 2018. Submit either electronic or written comments on the direct final rule or its companion proposed rule by April 11, 2018. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.
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.
FR Citation		83 FR 3586
RIN Number		0910-AH49
CFR Associated		Biologics and Reporting and Recordkeeping Requirements

83 FR 3586 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 18 (January 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration