83 FR 3631 - Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 18 (January 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3631-3635 | |
| FR Document | 2018-01467 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Proposed Rules] [Pages 3631-3635] From the Federal Register Online [www.thefederalregister.org] [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 FDA is proposing this action to remove outdated requirements and accommodate new approaches, [[Page 3632]] such as a risk-based inspection frequency for drug establishments, thereby providing flexibility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.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 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
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labor rate of $85 per hour, replacing a this proposed AD and placed it in the Engineer, DSCO Branch, AIR–7J0, FAA,
tube assembly would require about 6 AD docket. 10101 Hillwood Pkwy., Fort Worth, TX
work-hours and required parts would 76177; telephone (817) 222–5193; email
List of Subjects in 14 CFR Part 39 rory.rieger@faa.gov.
cost $4,902, for a total cost of $5,412 per
Air transportation, Aircraft, Aviation (2) For operations conducted under a 14
helicopter and $1,353,000 for the U.S. CFR part 119 operating certificate or under
fleet. safety, Incorporation by Reference,
14 CFR part 91, subpart K, we suggest that
According to Bell’s service Safety. you notify your principal inspector, or
information, some of the costs of this The Proposed Amendment lacking a principal inspector, the manager of
proposed AD may be covered under the local flight standards district office or
warranty, thereby reducing the cost Accordingly, under the authority certificate holding district office before
impact on affected individuals. We do delegated to me by the Administrator, operating any aircraft complying with this
not control warranty coverage by Bell. the FAA proposes to amend 14 CFR part AD through an AMOC.
Accordingly, we have included all costs 39 as follows: (g) Additional Information
in our cost estimate. Bell Helicopter Alert Service Bulletins
PART 39—AIRWORTHINESS
Authority for This Rulemaking DIRECTIVES 212–11–143 and 412–11–147, both Revision
C and dated December 22, 2016, which are
Title 49 of the United States Code ■ 1. The authority citation for part 39 not incorporated by reference, contain
specifies the FAA’s authority to issue continues to read as follows: additional information about the subject of
rules on aviation safety. Subtitle I, this AD. For service information identified in
Authority: 49 U.S.C. 106(g), 40113, 44701. this proposed rule, contact Bell Helicopter
section 106, describes the authority of
the FAA Administrator. ‘‘Subtitle VII: Textron, Inc., P.O. Box 482, Fort Worth, TX
§ 39.13 [Amended] 76101; telephone (817) 280–3391; fax (817)
Aviation Programs,’’ describes in more ■ 2. The FAA amends § 39.13 by adding 280–6466; or at http://
detail the scope of the Agency’s the following new airworthiness www.bellcustomer.com/files/. You may
authority. directive (AD): review a copy of information at the FAA,
We are issuing this rulemaking under Office of the Regional Counsel, Southwest
Bell Helicopter Textron Inc.: Docket No.
the authority described in ‘‘Subtitle VII, Region, 10101 Hillwood Pkwy., Room 6N–
FAA–2018–0036; Product Identifier
Part A, Subpart III, Section 44701: 321, Fort Worth, TX 76177.
2017–SW–015–AD.
General requirements.’’ Under that (h) Subject
section, Congress charges the FAA with (a) Applicability
Joint Aircraft Service Component (JASC)
promoting safe flight of civil aircraft in This AD applies to Bell Helicopter Textron
Code: 3212 Emergency Flotation Section.
air commerce by prescribing regulations Inc. (Bell) Model 212, Model 412, and Model
for practices, methods, and procedures 412EP helicopters, certificated in any Issued in Fort Worth, Texas, on January 12,
category, with an emergency flotation system 2018.
the Administrator finds necessary for
(EFS) tube assembly part number (P/N) 412– Scott A. Horn,
safety in air commerce. This regulation
073–820–101 with a date of manufacture Deputy Director for Regulatory Operations,
is within the scope of that authority before July 28, 2016, or an unknown date of
because it addresses an unsafe condition Compliance & Airworthiness Division,
manufacture installed. Aircraft Certification Service.
that is likely to exist or develop on
products identified in this rulemaking (b) Unsafe Condition [FR Doc. 2018–01195 Filed 1–25–18; 8:45 am]
action. This AD defines the unsafe condition as a BILLING CODE 4910–13–P
crack on an EFS tube assembly. This
Regulatory Findings condition could result in failure of the
We determined that this proposed AD emergency floats to inflate during an DEPARTMENT OF HEALTH AND
emergency water landing.
would not have federalism implications HUMAN SERVICES
under Executive Order 13132. This (c) Comments Due Date
proposed AD would not have a We must receive comments by March 27, Food and Drug Administration
substantial direct effect on the States, on 2018.
the relationship between the national 21 CFR Part 600
(d) Compliance
Government and the States, or on the [Docket No. FDA–2017–N–7007]
distribution of power and You are responsible for performing each
action required by this AD within the
responsibilities among the various specified compliance time unless it has
RIN 0910–AH49
levels of government. already been accomplished prior to that time.
For the reasons discussed, I certify Removal of Certain Time of Inspection
this proposed regulation: (e) Required Actions and Duties of Inspector Regulations
1. Is not a ‘‘significant regulatory (1) Within 300 hours time-in-service: for Biological Products; Companion to
action’’ under Executive Order 12866; (i) Remove the EFS tube assembly from Direct Final Rule
2. Is not a ‘‘significant rule’’ under the service.
(ii) Lubricate the shoulder of the sleeves, AGENCY: Food and Drug Administration,
DOT Regulatory Policies and Procedures threads, and seat of each mating fitting with HHS.
(44 FR 11034, February 26, 1979); anti-seize compound. ACTION: Proposed rule.
3. Will not affect intrastate aviation in (iii) Install an EFS tube assembly not listed
Alaska to the extent that it justifies in paragraph (a) of this AD. SUMMARY: The Food and Drug
daltland on DSKBBV9HB2PROD with PROPOSALS
making a regulatory distinction; and (2) After the effective date of this AD, do Administration (FDA, Agency, or we) is
4. Will not have a significant not install an EFS tube assembly listed in proposing to amend the general
economic impact, positive or negative, paragraph (a) of this AD on any helicopter. biologics regulations relating to time of
on a substantial number of small entities (f) Alternative Methods of Compliance inspection requirements and also
under the criteria of the Regulatory (AMOC) removing duties of inspector
Flexibility Act. (1) The Manager, DSCO Branch, FAA, may requirements. FDA is proposing this
We prepared an economic evaluation approve AMOCs for this AD. Send your action to remove outdated requirements
of the estimated costs to comply with proposal to: Rory Rieger, Aviation Safety and accommodate new approaches,
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C. Legal Authority adopt as final those provisions of the certain general biological products
FDA is proposing this action under rule that are not the subject of the regulations are designed to eliminate
the biological product provisions of the significant adverse comment. outdated requirements and
If any significant adverse comments to accommodate new approaches, such as
PHS Act, and the drugs and general
the direct final rule are received during a risk-based inspection frequency for
administrative provisions of the FD&C
the comment period, FDA will publish, drug establishments and provide
Act, including sections 704 and 510(h)
within 30 days after the comment flexibility without diminishing public
of the FD&C Act and section 351(c) of
period ends, a notice of significant health protections.
the PHS Act. adverse comment and withdraw the
direct final rule. If we withdraw the A. Section 600.21
D. Costs and Benefits
direct final rule, any comments received The authority for FDA to conduct
Because this proposed rule would not establishment inspections is included in
will be considered comments on the
impose any additional regulatory both the FD&C Act and the PHS Act.
proposed rule and will be considered in
burdens, this regulation is not Specifically, section 704 of the FD&C
developing a final rule using the usual
anticipated to result in any compliance Act and section 351(c) of the PHS Act
notice-and-comment procedure.
costs and the economic impact is If no significant adverse comment is authorize the Agency to inspect
expected to be minimal. received in response to the direct final establishments that manufacture
II. Companion Document to Direct rule during the comment period, no biological products. Before July 9,
Final Rulemaking further action will be taken related to 2012—the date the Food and Drug
this proposed rule. Instead, we will Administration Safety and Innovation
This proposed rule is a companion to Act (FDASIA) (Pub. L. 112–144) was
publish a document confirming the
the direct final rule published in the effective date within 30 days after the signed into law—section 510(h) of the
rules section of this issue of the Federal comment period ends. Additional FD&C Act further provided, among
Register. This companion proposed rule information about direct final other things, that drug and device
provides the procedural framework to rulemaking procedures is set forth in the establishments registered with FDA
finalize the rule in the event that the document entitled ‘‘Guidance for FDA must be inspected at least once in the
direct final rule receives any significant and Industry: Direct Final Rule 2-year period beginning with the date of
adverse comment and is withdrawn. Procedures,’’ announced and provided registration and at least once in every
The comment period for this companion in the Federal Register of November 21, successive 2-year period thereafter.
proposed rule runs concurrently with 1997 (62 FR 62466). The guidance may Section 510(h) of the FD&C Act applies
the comment period for the direct final be accessed at: https://www.fda.gov/ to biological product establishments
rule. Any comments received in RegulatoryInformation/Guidances/ because all biological products are
response to this companion proposed ucm125166.htm. subject to regulation under the drug or
rule will also be considered as device provisions of the FD&C Act (in
comments regarding the direct final III. Background
addition to the biological product
rule. FDA is publishing the direct final On February 24, 2017, President provisions of the PHS Act). Since 1983,
rule because we believe the rule Donald Trump issued Executive Order FDA’s biological product regulation at
contains noncontroversial changes and 13777, ‘‘Enforcing the Regulatory § 600.21 has also included a biennial
there is little likelihood that there will Reform Agenda’’ (82 FR 12285, March 1, inspection requirement (‘‘[A]n
be significant adverse comments 2017). One of the provisions in the inspection of each licensed
opposing the rule. Executive Order requires Agencies to establishment and its additional
A significant adverse comment is evaluate existing regulations and make location(s) shall be made at least once
defined as a comment that explains why recommendations to the Agency head every 2 years’’); this was consistent with
the rule would be inappropriate, regarding their repeal, replacement, or the pre-FDASIA biennial inspection
including challenges to the rule’s modification, consistent with applicable requirement in section 510(h) of the
underlying premise or approach, or law. As one step in implementing the FD&C Act.
would be ineffective or unacceptable Executive Order, FDA published a With the enactment of FDASIA,
without a change. In determining notice in the Federal Register of however, the biennial inspection
whether an adverse comment is September 8, 2017 (82 FR 42492) requirement for drug establishments in
significant and warrants terminating a entitled ‘‘Review of Existing Center for section 510(h) of the FD&C Act was
direct final rulemaking, we will Biologics Evaluation and Research replaced with a requirement that FDA
consider whether the comment raises an Regulatory and Information Collection inspect drug establishments in
issue serious enough to warrant a Requirements.’’ In that notice, FDA accordance with a risk-based schedule
substantive response in a notice-and- announced that it was conducting a established by FDA. Accordingly, for
comment process. Comments that are review of existing regulations to biological product establishments that
frivolous, insubstantial, or outside the determine, in part, whether they can be are registered as drug establishments
scope of the rule will not be considered made more effective in light of current under section 510(h), the requirement in
significant or adverse under this public health needs and to take § 600.21 regarding the frequency of
procedure. A comment recommending a advantage of, and support, advances in inspections is no longer consistent with
regulation change in addition to those in innovation that have occurred since the FD&C Act and is outdated (e.g., the
the direct final rule would not be those regulations took effect. As part of risk-based inspection schedule for drug
daltland on DSKBBV9HB2PROD with PROPOSALS
considered a significant adverse this initiative, FDA is updating outdated establishments may result in scheduling
comment unless the comment states regulations as specified in this rule. inspections at intervals of greater than 2
why the rule would be ineffective FDA’s general biological products years for certain biological product
without the additional change. In regulations in part 600 (21 CFR part establishments). For this reason, and to
addition, if a significant adverse 600) are intended to help ensure the provide for greater flexibility in general
comment applies to a part of the direct safety, purity, and potency of biological with respect to determining the
final rule and that part can be severed products administered to humans. The frequency of biological product
from the remainder of the rule, we may proposed revision and removal of establishment inspections under the
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![Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3635
Health Service Act, and under authority of Housing and Urban Development, I. Executive Orders 13771 and 13777
delegated to the Commissioner of Food 451 7th Street SW, Room 10276, Under the leadership of Secretary
and Drugs, it is proposed that 21 CFR Washington, DC 20410–0500. Carson, HUD has undertaken an effort,
part 600 be amended as follows: Communications must refer to the above consistent with Executive Order 13771
docket number and title. (82 FR 9339), entitled ‘‘Reducing
PART 600—BIOLOGICAL PRODUCTS:
Electronic Submission of Comments. Regulation and Controlling Regulatory
GENERAL
Interested persons may submit Costs,’’ to identify and eliminate or
■ 1. The authority citation for part 600 comments electronically through the streamline regulations that are wasteful,
continues to read as follows: Federal eRulemaking Portal at inefficient or unnecessary. Executive
www.regulations.gov. HUD strongly Order 13771 requires that agencies
Authority: 21 U.S.C. 321, 351, 352, 353, encourages commenters to submit manage the costs associated with the
355, 356c, 356e, 360, 360i, 371, 374, 379k–
l; 42 U.S.C. 216, 262, 263, 263a, 264, 300aa–
comments electronically. Electronic governmental imposition of private
25. submission of comments allows the expenditures required to comply with
commenter maximum time to prepare Federal regulations. Toward this end,
§ 600.21 [Amended] and submit a comment, ensures timely Executive Order 13771 directs that for
■ 2. Amend § 600.21 by removing the receipt by HUD, and enables HUD to each new regulation issued, at least two
last three sentences. make them immediately available to the prior regulations be identified for
public. Comments submitted elimination and requires that the cost of
§ 600.22 [Removed and Reserved] electronically through the planned regulations be prudently
■ 3. Remove and reserve § 600.22. www.regulations.gov website can be managed and controlled. In furtherance
Dated: January 23, 2018. viewed by other commenters and of this objective, the Secretary has also
Leslie Kux, interested members of the public. led HUD’s implementation of Executive
Associate Commissioner for Policy.
Commenters should follow the Order 13777 (82 FR 12285), entitled
instructions provided on that site to ‘‘Enforcing the Regulatory Reform
[FR Doc. 2018–01467 Filed 1–25–18; 8:45 am]
submit comments electronically. Agenda.’’ Executive Order 13777
BILLING CODE 4164–01–P
Note: To receive consideration as reaffirms the rulemaking principles of
public comments, comments must be Executive Order 13771 by directing each
submitted through one of the two agency to establish a Regulatory Reform
DEPARTMENT OF HOUSING AND methods specified above. Again, all Task Force to evaluate existing
URBAN DEVELOPMENT submissions must refer to the docket regulations to identify those that merit
number and title of the notice. repeal, replacement, modification, are
24 CFR Parts 3280, 3282, and 3285 outdated, unnecessary, or are
No Facsimile Comments. Facsimile
[Docket No. FR–6075–N–01] ineffective, eliminate or inhibit job
(fax) comments are not acceptable.
creation, impose costs that exceed
Regulatory Review of Manufactured Public Inspection of Public benefits, or derive from or implement
Housing Rules Comments. All properly submitted Executive Orders that have been
comments and communications rescinded or significantly modified.
AGENCY: Office of the Assistant submitted to HUD will be available for
Secretary for Housing—Federal Housing public inspection and copying between II. This Notice
Commissioner, Department of Housing 8 a.m. and 5 p.m. weekdays at the above Manufactured housing plays a vital
and Urban Development, HUD. address. Due to security measures at the role in meeting the nation’s affordable
ACTION: Request for comments on HUD Headquarters building, an housing needs, providing 9.5 percent of
regulatory review. appointment to review the public the total single-family housing stock.1
comments must be scheduled in According to the Manufactured Housing
SUMMARY: Consistent with Executive advance by calling the Regulations Institute,2 more than 22 million
Order 13771 entitled ‘‘Reducing Division at 202–708–3055 (this is not a Americans reside in manufactured
Regulation and Controlling Regulatory toll-free number). Individuals with housing. Manufactured homes are
Costs,’’ and Executive Order 13777 speech or hearing impairments may particularly important in rural states,
entitled, ‘‘Enforcing the Regulatory access this number via TTY by calling where manufactured homes are
Reform Agenda,’’ and as part of the the Federal Relay Service at 1–800–877– approximately 16.2 percent of occupied
efforts of HUD’s Regulatory Reform Task 8339 (this is a toll-free number). Copies housing units. The manufactured
Force, this document informs the public of all comments submitted are available housing industry is also an important
that HUD is reviewing its existing and for inspection and downloading at economic engine, accounting for
planned manufactured housing www.regulations.gov. approximately 35,000 jobs nationwide.
regulatory actions to assess their actual HUD regulation of manufactured
and potential compliance costs and FOR FURTHER INFORMATION CONTACT: housing fulfills a critical role of both
reduce regulatory burden. HUD invites Ariel Pereira, Associate General Counsel protecting consumers and ensuring a
public comment to assist in identifying for Legislation and Regulations, Office fair and efficient market. HUD may
regulations that may be outmoded, of General Counsel, Department of adopt, revise, and interpret HUD’s
ineffective or excessively burdensome Housing and Urban Development, 451 manufactured housing program
and should be modified, streamlined, 7th Street SW, Room 10282, Washington
daltland on DSKBBV9HB2PROD with PROPOSALS
regulations based on recommendations
replaced or repealed. DC 20410; telephone number 202–402– of the Manufactured Housing Consensus
DATES: Comment Due Date: February 26, 5138 (this is not a toll-free number).
2018. Persons with hearing or speech 1 American Housing Survey, 2013. Available at:
impairments may access this number http://factfinder2.census.gov/faces/tableservices/
ADDRESSES: Interested persons are
through TTY by calling the toll-free jsf/pages/productview.xhtml?pid=AHS_2013_
invited to submit comments regarding C01AH&prodType=table.
Federal Relay Service at 800–877–8339.
this notice to the Regulations Division, 2 http://www.manufacturedhousing.org/research-
Office of General Counsel, Department SUPPLEMENTARY INFORMATION: and-data/.
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Document Created: 2018-10-26 10:04:51
Document Modified: 2018-10-26 10:04:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| 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. | |
| 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 3631 | |
| RIN Number | 0910-AH49 | |
| CFR Associated | Biologics and Reporting and Recordkeeping Requirements |
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