Document ID: FDA-2017-N-5092-0001
Agency: fda
Document Type: Proposed Rule
Title: Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements
Posted Date: 2017-09-08T04:00Z

[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Proposed Rules]
[Pages 42492-42494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2017-N-5092]

Review of Existing Center for Biologics Evaluation and Research 
Regulatory and Information Collection Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments and information.

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SUMMARY: As part of the implementation of Executive Order 13771 
entitled, ``Reducing Regulation and Controlling Regulatory Costs,'' and 
Executive Order 13777 entitled, ``Enforcing the Regulatory Reform 
Agenda,'' the Food and Drug Administration (FDA, Agency, or we) is 
seeking comments and information from interested parties to help FDA 
identify existing regulations and related paperwork requirements that 
could be modified, repealed, or replaced, consistent with the law, to 
achieve meaningful burden reduction while allowing us to achieve our 
public health mission and fulfill statutory obligations. This document 
relates to the products regulated by the Center for Biologics 
Evaluation and Research (CBER).

DATES: Submit either electronic or written comments on this document by 
December 7, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of December 7, 2017. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions.'')

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as

[[Page 42493]]

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-5092 for ``Review of Existing Center for Biologics 
Evaluation and Research Regulatory and Information Collection 
Requirements.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff Office between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff Office, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, 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. Background

A. FDA's Regulatory Mission

    FDA is responsible for protecting the public health by: (1) 
Ensuring the safety, efficacy, and security of human and veterinary 
drugs, biological products, and medical devices; (2) ensuring the 
safety, security, and appropriate labeling of our nation's food supply, 
products that emit radiation, and cosmetics; and (3) regulating the 
manufacture, marketing, and distribution of tobacco products. Equally 
important, FDA promotes the public health by fostering and supporting 
innovative approaches and solutions for some of our nation's most 
compelling health and medical challenges.
    FDA's CBER regulates a wide range of biological products and 
related products including: Allergenics, blood and blood products, 
certain medical devices for blood and tissues, gene therapies, human 
cells, tissues, and cellular and tissue-based products, vaccines, and 
xenotransplantation products. This document is seeking comments and 
information solely on regulations and approved information collections 
related to these product areas.

B. The Regulatory Reform Agenda: Executive Orders 13771 and 13777

    On January 30, 2017, President Trump issued Executive Order 13771, 
``Reducing Regulation and Controlling Regulatory Costs'' (Ref. 1). This 
Executive Order states that the policy of the Executive Branch is to be 
prudent and financially responsible in the expenditure of funds, from 
both public and private sources, and that it is essential to manage the 
costs associated with complying with Federal regulations. On February 
24, 2017, President Trump issued Executive Order 13777, entitled 
``Enforcing the Regulatory Reform Agenda'' (Ref. 2). The purpose of 
this Executive Order is to alleviate unnecessary regulatory burdens 
placed on the American people. Executive Order 13777 directs each 
Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate 
existing regulations and identify those that may merit repeal, 
replacement, or modification. Section 3(d) of the Executive Order 
provides that, at a minimum, each RRTF must attempt to identify 
regulations that:
     Eliminate jobs, or inhibit job creation;
     Are outdated, unnecessary, or ineffective;
     Impose costs that exceed benefits;
     Create a serious inconsistency or otherwise interfere with 
regulatory reform initiatives and policies;
     Are inconsistent with the requirements of the Information 
Quality Act, or the guidance issued pursuant to that Act, in particular 
those regulations that rely in whole or in part on data, information, 
or methods that are not publicly available or that are insufficiently 
transparent to meet the standard for reproducibility; or
     Derive from or implement Executive Orders or other 
Presidential directives that have been subsequently rescinded or 
substantially modified.

II. Request for Comments and Information

    To assist with our implementation of Executive Orders 13771 and 
13777 and support the work of the RRTF of the Department of Health and 
Human Services, FDA is issuing this Request for Information soliciting 
broad public comment on ways we can change our regulations to achieve 
meaningful burden reduction while continuing to achieve our public 
health mission and fulfill statutory obligations. We request comment, 
including supporting technical, scientific, economic, or other data, 
from all persons and entities significantly affected by FDA 
regulations, including consumers, patients and caregivers, researchers, 
healthcare institutions, the regulated industry, trade associations, 
public interest organizations, academia, and State, local, and tribal 
governments, as well as any other interested stakeholder. These 
comments and data will supplement and inform our own ongoing, 
systematic review of our regulations.
    The following list of questions includes those that FDA is using to 
guide our initial review of our regulations. This list is intended to 
help the public in providing comments, not to restrict the issues that 
may be addressed.
     Is the regulation still current, or is it outdated or 
unnecessary in some way?
    [cir] Have there been advancements and innovations in science, 
technology, or FDA or industry practice, or any other changes that 
suggest repeal of or modification to the regulation may be warranted or 
appropriate?
    [cir] Has the regulation been superseded or made irrelevant or 
unenforceable by statute, another FDA regulation or guidance, a 
regulation by another

[[Page 42494]]

Federal Agency, or controlling legal authority? If yes, identify the 
statute, regulation, guidance, or legal precedent and explain what FDA 
regulation is affected and in what way it is affected.
    [cir] Is this regulation duplicative of requirements in other FDA 
regulations or other Federal Agency regulations? If yes, identify the 
overlapping regulation(s) and responsible Federal Agency and describe 
the way(s) in which the regulations overlap, as well as any suggestions 
with respect to how best to resolve the duplication.
     Have regulated entities had difficulties complying with 
the regulation? If yes, identify what entity or entities have had such 
difficulties and the nature of the difficulties.
     Does the regulation impose requirements that are also 
provided for in voluntary or consensus standards or guidance by third 
party organizations (e.g., International Council for Harmonisation, 
International Organization for Standardization, Codex Alimentarius)? Do 
the entities covered by these standards or guidance take steps to meet 
the standards and to document that they meet the standards? If met, do 
the standards achieve the same level of public health protection as the 
FDA regulation? Are there entities who are not covered by these 
standards or guidances or who choose not to observe them?
     Does the regulation contain redundant, outdated, or 
unnecessary collections of information or retention of records, e.g., 
reporting, recordkeeping, or labeling requirements? Explain in your 
response why the information is redundant, outdated, or unnecessary.
     Could the goal of the regulation be achieved by less 
costly means that would provide the same level of public health 
protection? If yes, provide examples of alternatives that may reduce 
costs to industry while retaining the same level of public health 
protection.
     What factors should FDA consider in selecting and 
prioritizing regulations and reporting requirements for reform?
    The most current version of FDA regulations may be found at https://www.ecfr.gov. We request that comments be as specific as possible, 
include any supporting data or other information, such as cost 
information, provide a Code of Federal Regulations (CFR) citation when 
referencing a specific regulation, and provide specific suggestions 
regarding repeal, replacement, or modification. For comments relating 
to an information collection, cite to the approved information 
collection request and include the Office of Management and Budget 
(OMB) control number.
    In addition, in order to enable us to more efficiently review and 
consider comments, we ask that the comments be submitted in the format 
shown in table 1 of this document.

                 Table 1--Format for Submitting Comments
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           Name of regulation
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Type of product or FDA Center
 regulating the product.
Citation to Code of Federal Regulations
 and statutory citation (as
 applicable).
Approved information collection and OMB
 Control Number (as applicable).
Brief description of concern...........  (For example, what innovation
                                          makes the regulation outdated?
                                          Why?)
Available data on cost or economic       (Quantified costs and/or cost
 impact.                                  savings. Qualitative
                                          description, if needed.)
Proposed solution......................  (Include your solution. For
                                          example, how would you modify
                                          the regulation? Provide
                                          specific text if you are
                                          recommending a modification.)
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III. References

    The following references are on display in the Dockets Management 
Staff Office (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Executive Order 13771 (January 30, 2017); available at https://www.federalregister.gov/documents/2017/02/03/2017-02451/reducing-regulation-and-controlling-regulatory-costs.
2. Executive Order 13777 (February 24, 2017); available at https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda.

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-19032 Filed 9-7-17; 8:45 am]
BILLING CODE 4164-01-P