82 FR 42494 - Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 173 (September 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 173 (September 8, 2017)
| Page Range | 42494-42497 | |
| FR Document | 2017-19034 |
[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)] [Proposed Rules] [Pages 42494-42497] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19034] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2017-N-5105] Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Request for comments and information. ----------------------------------------------------------------------- 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interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory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 Devices and Radiological Health (CDRH). 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 [[Page 42495]] considered. Electronic comments must be submitted on or before December 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 7, 2017. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions.'') Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-5105 for ``Review of Existing Center for Devices and Radiological Health 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.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 Office, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Erica Blake Payne, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3999, [email protected]. SUPPLEMENTARY INFORMATION: I. Background A. FDA's Regulatory Mission FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges. FDA's CDRH regulates medical devices from simple tongue depressors to complex programmable pacemakers and laser-based surgical devices. Medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. CDRH also regulates radiation emitting electronic products. Electronic products include certain medical devices (e.g., diagnostic ultrasound products, x-ray machines, and medical lasers) and certain products without medical applications (e.g., microwave ovens, television receivers and monitors). 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; [[Page 42496]] 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 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 ------------------------------------------------------------------------ Name of regulation ------------------------------------------------------------------------ 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.) ------------------------------------------------------------------------ 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:// [[Page 42497]] 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. 2017-19034 Filed 9-7-17; 8:45 am] BILLING CODE 4164-01-P
![42494 Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules
Federal Agency, or controlling legal Alimentarius)? Do the entities covered • What factors should FDA consider
authority? If yes, identify the statute, by these standards or guidance take in selecting and prioritizing regulations
regulation, guidance, or legal precedent steps to meet the standards and to and reporting requirements for reform?
and explain what FDA regulation is document that they meet the standards? The most current version of FDA
affected and in what way it is affected. If met, do the standards achieve the
Æ Is this regulation duplicative of regulations may be found at https://
same level of public health protection as
requirements in other FDA regulations www.ecfr.gov. We request that
the FDA regulation? Are there entities
or other Federal Agency regulations? If who are not covered by these standards comments be as specific as possible,
yes, identify the overlapping or guidances or who choose not to include any supporting data or other
regulation(s) and responsible Federal observe them? information, such as cost information,
Agency and describe the way(s) in • Does the regulation contain provide a Code of Federal Regulations
which the regulations overlap, as well redundant, outdated, or unnecessary (CFR) citation when referencing a
as any suggestions with respect to how collections of information or retention specific regulation, and provide specific
best to resolve the duplication. of records, e.g., reporting, suggestions regarding repeal,
• Have regulated entities had recordkeeping, or labeling replacement, or modification. For
difficulties complying with the requirements? Explain in your response comments relating to an information
regulation? If yes, identify what entity why the information is redundant, collection, cite to the approved
or entities have had such difficulties outdated, or unnecessary. information collection request and
and the nature of the difficulties. • Could the goal of the regulation be include the Office of Management and
• Does the regulation impose achieved by less costly means that Budget (OMB) control number.
requirements that are also provided for would provide the same level of public
in voluntary or consensus standards or health protection? If yes, provide In addition, in order to enable us to
guidance by third party organizations examples of alternatives that may more efficiently review and consider
(e.g., International Council for reduce costs to industry while retaining comments, we ask that the comments be
Harmonisation, International the same level of public health submitted in the format shown in table
Organization for Standardization, Codex protection. 1 of this document.
TABLE 1—FORMAT FOR SUBMITTING COMMENTS
Name of regulation
Type of product or FDA Center regulating the product.
Citation to Code of Federal Regulations and statutory citation (as appli-
cable).
Approved information collection and OMB Control Number (as applica-
ble).
Brief description of concern ...................................................................... (For example, what innovation makes the regulation outdated? Why?)
Available data on cost or economic impact ............................................. (Quantified costs and/or cost savings. Qualitative description, if need-
ed.)
Proposed solution ..................................................................................... (Include your solution. For example, how would you modify the regula-
tion? Provide specific text if you are recommending a modification.)
III. References Dated: August 30, 2017. SUMMARY: As part of the implementation
Anna K. Abram, of Executive Order 13771 entitled,
The following references are on Deputy Commissioner for Policy, Planning, ‘‘Reducing Regulation and Controlling
display in the Dockets Management Legislation, and Analysis. Regulatory Costs,’’ and Executive Order
Staff Office (see ADDRESSES) and are [FR Doc. 2017–19032 Filed 9–7–17; 8:45 am] 13777 entitled, ‘‘Enforcing the
available for viewing by interested BILLING CODE 4164–01–P Regulatory Reform Agenda,’’ the Food
persons between 9 a.m. and 4 p.m., and Drug Administration (FDA, Agency,
Monday through Friday; they are also or we) is seeking comments and
available electronically at https:// DEPARTMENT OF HEALTH AND information from interested parties to
www.regulations.gov. FDA has verified HUMAN SERVICES help FDA identify existing regulations
the Web site addresses, as of the date and related paperwork requirements
this document publishes in the Federal Food and Drug Administration that could be modified, repealed, or
Register, but Web sites are subject to replaced, consistent with the law, to
change over time. 21 CFR Chapter I achieve meaningful burden reduction
while allowing us to achieve our public
1. Executive Order 13771 (January 30, 2017);
[Docket No. FDA–2017–N–5105] health mission and fulfill statutory
available at https://
obligations. This document relates to
www.federalregister.gov/documents/ Review of Existing Center for Devices the products regulated by the Center for
2017/02/03/2017-02451/reducing-
sradovich on DSK3GMQ082PROD with PROPOSALS
and Radiological Health Regulatory Devices and Radiological Health
regulation-and-controlling-regulatory-
and Information Collection (CDRH).
costs.
Requirements
2. Executive Order 13777 (February 24, DATES: Submit either electronic or
2017); available at https:// AGENCY: Food and Drug Administration, written comments on this document by
www.federalregister.gov/documents/ HHS. December 7, 2017.
2017/03/01/2017-04107/enforcing-the- ADDRESSES: You may submit comments
regulatory-reform-agenda. ACTION:Request for comments and
as follows. Please note that late,
information.
untimely filed comments will not be
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![Federal Register / Vol. 82, No. 173 / Friday, September 8, 2017 / Proposed Rules 42497
www.federalregister.gov/documents/2017/02/ service acceptance receipt is on or submission. You should submit two
03/2017-02451/reducing-regulation-and- before that date. copies total. One copy will include the
controlling-regulatory-costs. information you claim to be confidential
2. Executive Order 13777 (February 24, Electronic Submissions
with a heading or cover note that states
2017); available at https:// Submit electronic comments in the
www.federalregister.gov/documents/2017/03/
‘‘THIS DOCUMENT CONTAINS
following way: CONFIDENTIAL INFORMATION.’’ We
01/2017-04107/enforcing-the-regulatory-
• Federal eRulemaking Portal: will review this copy, including the
reform-agenda.
https://www.regulations.gov. Follow the claimed confidential information, in our
Dated: August 30, 2017. instructions for submitting comments. consideration of comments. The second
Anna K. Abram, Comments submitted electronically, copy, which will have the claimed
Deputy Commissioner for Policy, Planning, including attachments, to https:// confidential information redacted/
Legislation, and Analysis. www.regulations.gov will be posted to blacked out, will be available for public
[FR Doc. 2017–19034 Filed 9–7–17; 8:45 am] the docket unchanged. Because your viewing and posted on https://
BILLING CODE 4164–01–P comment will be made public, you are www.regulations.gov. Submit both
solely responsible for ensuring that your copies to the Dockets Management Staff.
comment does not include any If you do not wish your name and
DEPARTMENT OF HEALTH AND confidential information that you or a contact information to be made publicly
HUMAN SERVICES third party may not wish to be posted, available, you can provide this
such as medical information, your or information on the cover sheet and not
Food and Drug Administration anyone else’s Social Security number, or in the body of your comments and you
confidential business information, such must identify this information as
21 CFR Chapter I as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
that if you include your name, contact as ‘‘confidential’’ will not be disclosed
[Docket No. FDA–2017–N–5104] information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
Review of Existing Center for
comments, that information will be more information about FDA’s posting
Veterinary Medicine Regulatory and
posted on https://www.regulations.gov. of comments to public dockets, see 80
Information Collection Requirements • If you want to submit a comment FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, with confidential information that you the information at: https://www.gpo.gov/
HHS. do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
ACTION:Request for comments and public, submit the comment as a 23389.pdf
information. written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
SUMMARY: As part of the implementation Submissions’’ and ‘‘Instructions.’’) electronic and written/paper comments
of Executive Order 13771 entitled, Written/Paper Submissions received, go to https://
‘‘Reducing Regulation and Controlling www.regulations.gov and insert the
Regulatory Costs,’’ and Executive Order Submit written/paper submissions as
follows: docket number, found in brackets in the
13777 entitled, ‘‘Enforcing the heading of this document, into the
Regulatory Reform Agenda,’’ the Food • Mail/Hand delivery/Courier (for
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
and Drug Administration (FDA, Agency, and/or go to the Dockets Management
or we) is seeking comments and Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers Staff Office, 5630 Fishers Lane, Rm.
information from interested parties to 1061, Rockville, MD 20852.
help FDA identify existing regulations Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT:
and related paperwork requirements
submitted to the Dockets Management Diane Heinz, Center for Veterinary
that could be modified, repealed, or
Staff, FDA will post your comment, as Medicine (HFV–6), Food and Drug
replaced, consistent with the law, to
well as any attachments, except for Administration, 7500 Standish Pl.,
achieve meaningful burden reduction
information submitted, marked and Rockville, MD 20855, 240–402–5692,
while allowing us to achieve our public
identified, as confidential, if submitted diane.heinz@fda.hhs.gov.
health mission and fulfill statutory
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION:
obligations. This document relates to
Instructions: All submissions received
the products regulated by the Center for I. Background
must include the Docket No. FDA–
Veterinary Medicine (CVM).
2017–N–5104 for ‘‘Review of Existing A. FDA’s Regulatory Mission
DATES: Submit either electronic or Center for Veterinary Medicine
written comments on this document by Regulatory and Information Collection FDA is responsible for protecting the
December 7, 2017. Requirements.’’ Received comments, public health by: (1) Ensuring the safety,
ADDRESSES: You may submit comments those filed in a timely manner (see efficacy, and security of human and
as follows. Please note that late, ADDRESSES), will be placed in the docket veterinary drugs, biological products,
untimely filed comments will not be and, except for those submitted as and medical devices; (2) ensuring the
considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly safety, security, and appropriate
be submitted on or before December 7, viewable at https://www.regulations.gov labeling of our nation’s food supply,
sradovich on DSK3GMQ082PROD with PROPOSALS
2017. The https://www.regulations.gov or at the Dockets Management Staff products that emit radiation, and
electronic filing system will accept Office between 9 a.m. and 4 p.m., cosmetics; and (3) regulating the
comments until midnight Eastern Time Monday through Friday. manufacture, marketing, and
at the end of December 7, 2017. • Confidential Submissions—To distribution of tobacco products.
Comments received by mail/hand submit a comment with confidential Equally important, FDA promotes the
delivery/courier (for written/paper information that you do not wish to be public health by fostering and
submissions) will be considered timely made publicly available, submit your supporting innovative approaches and
if they are postmarked or the delivery comments only as a written/paper solutions for some of our nation’s most
VerDate Sep<11>2014 16:39 Sep 07, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\08SEP1.SGM 08SEP1](https://thefederalregister.org/doc/82_FR_42667/page/4.svg)
Document Created: 2018-10-24 14:08:40
Document Modified: 2018-10-24 14:08:40
| 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 | Request for comments and information. | |
| Dates | Submit either electronic or written comments on this document by December 7, 2017. | |
| Contact | Erica Blake Payne, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3999, cdrh- [email protected] | |
| FR Citation | 82 FR 42494 |
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