83 FR 2758 - Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 13 (January 19, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 13 (January 19, 2018)
| Page Range | 2758-2759 | |
| FR Document | 2018-00918 |
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)] [Proposed Rules] [Pages 2758-2759] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-00918] [[Page 2758]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 7 [Docket No. FDA-2016-D-3548] Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.'' The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification. DATES: Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: 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-2016-D-3548 for ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.'' Received comments 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-8186, [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.'' The draft guidance, when finalized, will establish official guidance for industry and FDA staff regarding the use, content, and timing of public warnings and public notification of recalls under part 7 (21 CFR part 7). The draft guidance is part of a larger effort FDA is undertaking to give additional guidance to industry and FDA staff regarding the execution and oversight of voluntary recalls under part 7. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on public warnings and notification of recalls. It does not establish any rights for any person and is not binding on [[Page 2759]] FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520). Any collection of information, including a firm's public warning (Sec. 7.42(b)(2)), has been approved under OMB control number 0910- 0249. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Safety/Recalls/default.htm or https://www.regulations.gov. Dated: January 16, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-00918 Filed 1-18-18; 8:45 am] BILLING CODE 4164-01-P
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DEPARTMENT OF HEALTH AND as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
HUMAN SERVICES that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
Food and Drug Administration identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
21 CFR Part 7 posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
[Docket No. FDA–2016–D–3548]
• If you want to submit a comment the information at: https://www.gpo.gov/
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Public Warning and Notification of do not wish to be made available to the 23389.pdf.
Recalls Under 21 CFR Part 7, Subpart public, submit the comment as a Docket: For access to the docket to
C; Draft Guidance for Industry and written/paper submission and in the read background documents or the
Food and Drug Administration Staff; manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Availability Submissions’’ and ‘‘Instructions’’). received, go to https://
Written/Paper Submissions www.regulations.gov and insert the
AGENCY: Food and Drug Administration, docket number, found in brackets in the
HHS. Submit written/paper submissions as heading of this document, into the
ACTION: Notification of availability. follows: ‘‘Search’’ box and follow the prompts
• Mail/Hand delivery/Courier (for
SUMMARY: The Food and Drug and/or go to the Dockets Management
written/paper submissions): Dockets
Administration (FDA or Agency) is Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and
announcing the availability of a draft Rockville, MD 20852.
Drug Administration, 5630 Fishers
guidance entitled ‘‘Public Warning and You may submit comments on any
Lane, Rm. 1061, Rockville, MD 20852.
Notification of Recalls Under 21 CFR • For written/paper comments guidance at any time (see 21 CFR
Part 7, Subpart C; Draft Guidance for submitted to the Dockets Management 10.115(g)(5)).
Industry and FDA Staff.’’ The draft Staff, FDA will post your comment, as Submit written requests for single
guidance, when finalized, establishes well as any attachments, except for copies of the draft guidance to the Office
official guidance for industry and FDA information submitted, marked and of Strategic Planning and Operational
staff regarding the use, content, and identified, as confidential, if submitted Policy, Office of Regulatory Affairs,
circumstances for issuance of public as detailed in ‘‘Instructions.’’ Food and Drug Administration, 12420
warnings and public notification of Instructions: All submissions received Parklawn Dr., Element Building,
voluntary recalls under Federal must include the Docket No. FDA– Rockville, MD 20857. Send one self-
regulations. The intent of the draft 2016–D–3548 for ‘‘Public Warning and addressed adhesive label to assist that
guidance is to increase and expedite the Notification of Recalls Under 21 CFR office in processing your requests. See
appropriate and accurate use of public Part 7, Subpart C; Draft Guidance for the SUPPLEMENTARY INFORMATION section
warnings and public notification, to Industry and FDA Staff.’’ Received for electronic access to the draft
increase public health protection by comments will be placed in the docket guidance document.
better informing the public about and, except for those submitted as FOR FURTHER INFORMATION CONTACT:
violative products being recalled. The ‘‘Confidential Submissions,’’ publicly Chris Henderson, Office of Regulatory
draft guidance clarifies and viewable at https://www.regulations.gov Affairs, Food and Drug Administration,
supplements existing policy for industry or at the Dockets Management Staff 12420 Parklawn Dr., Rockville, MD
and FDA staff regarding the use of between 9 a.m. and 4 p.m., Monday 20857, 240–402–8186,
public warnings and public notification. through Friday. Christopher.henderson@fda.hhs.gov.
DATES: Submit either electronic or • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
written comments on the draft guidance submit a comment with confidential
information that you do not wish to be I. Background
by March 20, 2018 to ensure that the
Agency considers your comment on this made publicly available, submit your FDA is announcing the availability of
draft guidance before it begins work on comments only as a written/paper a draft guidance for industry and FDA
the final version of the guidance. submission. You should submit two staff entitled ‘‘Public Warning and
ADDRESSES: You may submit comments copies total. One copy will include the Notification of Recalls Under 21 CFR
on any guidance at any time as follows: information you claim to be confidential Part 7, Subpart C.’’ The draft guidance,
with a heading or cover note that states when finalized, will establish official
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS guidance for industry and FDA staff
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The regarding the use, content, and timing of
following way: Agency will review this copy, including public warnings and public notification
• Federal eRulemaking Portal: the claimed confidential information, in of recalls under part 7 (21 CFR part 7).
https://www.regulations.gov. Follow the its consideration of comments. The The draft guidance is part of a larger
instructions for submitting comments. second copy, which will have the effort FDA is undertaking to give
Comments submitted electronically, claimed confidential information additional guidance to industry and
including attachments, to https:// redacted/blacked out, will be available FDA staff regarding the execution and
www.regulations.gov will be posted to for public viewing and posted on oversight of voluntary recalls under part
the docket unchanged. Because your https://www.regulations.gov. Submit 7.
daltland on DSKBBV9HB2PROD with PROPOSALS
comment will be made public, you are both copies to the Dockets Management This draft guidance is being issued
solely responsible for ensuring that your Staff. If you do not wish your name and consistent with FDA’s good guidance
comment does not include any contact information to be made publicly practices regulation (21 CFR 10.115).
confidential information that you or a available, you can provide this The draft guidance, when finalized, will
third party may not wish to be posted, information on the cover sheet and not represent the current thinking of FDA
such as medical information, your or in the body of your comments and you on public warnings and notification of
anyone else’s Social Security number, or must identify this information as recalls. It does not establish any rights
confidential business information, such ‘‘confidential.’’ Any information marked for any person and is not binding on
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![Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Proposed Rules 2759
FDA or the public. You can use an outdated, unnecessary, ineffective, FOR FURTHER INFORMATION CONTACT: Raul
alternative approach if it satisfies the costly, or unduly burdensome on the Tamayo, Senior Legal Advisor, Office of
requirements of the applicable statutes agency or the private sector. The Patent Legal Administration, at (571)
and regulations. This draft guidance is revisions proposed herein would put 272–7728, for questions regarding the
not subject to Executive Order 12866. into effect the work the USPTO has changes to 37 CFR 1.79 and/or 1.127;
done, in part through its participation in Susan L. C. Mitchell, Lead
II. Paperwork Reduction Act of 1995 the Regulatory Reform Task Force Administrative Patent Judge, Patent
This draft guidance refers to established by the Department of Trial and Appeal Board, at (571) 272–
previously approved collections of Commerce pursuant to Executive Order 8715, for questions regarding the
information that are subject to review by 13777, to review and identify changes to 37 CFR part 42; and Nicolas
the Office of Management and Budget regulations that are candidates for Oettinger, Senior Counsel for Regulatory
(OMB) under the Paperwork Reduction removal. and Legislative Affairs, Office of the
Act of 1995 (44 U.S.C. 3501–3520). Any DATES: Written comments must be General Counsel, at (571) 272–7832, for
collection of information, including a received on or before February 20, 2018. questions regarding the change to 37
firm’s public warning (§ 7.42(b)(2)), has CFR 1.351 and general questions
ADDRESSES: Comments on the changes
been approved under OMB control regarding regulatory reform.
set forth in this proposed rulemaking
number 0910–0249. SUPPLEMENTARY INFORMATION:
should be sent by electronic mail
III. Electronic Access message to: AD25.comments@uspto.gov. I. Background
Persons with access to the internet Comments may also be submitted by
postal mail addressed to: Mail Stop In accordance with Executive Order
may obtain the draft guidance at either
Comments—Patents, Commissioner for 13777, ‘‘Enforcing the Regulatory
https://www.fda.gov/Safety/Recalls/
Patents, P.O. Box 1450, Alexandria, VA, Reform Agenda,’’ the Department of
default.htm or https://
22313–1450, marked to the attention of Commerce established a Regulatory
www.regulations.gov.
Raul Tamayo, Senior Legal Advisor, Reform Task Force (Task Force),
Dated: January 16, 2018. comprising, among others, agency
Office of Patent Legal Administration.
Leslie Kux, Comments concerning ideas to improve, officials from the National Oceanic and
Associate Commissioner for Policy. revise, and streamline other USPTO Atmospheric Administration, the
[FR Doc. 2018–00918 Filed 1–18–18; 8:45 am] regulations, not discussed in this Bureau of Industry and Security, and
BILLING CODE 4164–01–P proposed rulemaking, should be the USPTO, and charged the Task Force
submitted to: RegulatoryReformGroup@ with evaluating existing regulations and
uspto.gov. identifying those that should be
DEPARTMENT OF COMMERCE Comments may also be submitted via repealed, replaced, or modified because
the Federal eRulemaking Portal at they are potentially outdated,
United States Patent and Trademark http://www.regulations.gov. See the unnecessary, ineffective, costly, or
Office Federal eRulemaking Portal website for unduly burdensome to both government
additional instructions on providing and private sector operations.
37 CFR Parts 1 and 42 comments via the Federal eRulemaking To support its regulatory reform
Portal. Although comments may be efforts on the Task Force, the USPTO
[Docket No.: PTO–P–2017–0034]
submitted by postal mail, the Office assembled a Working Group on
RIN 0651–AD25 prefers to receive comments by Regulatory Reform (Working Group),
electronic mail message over the consisting of subject matter experts from
Changes To Eliminate Unnecessary internet because the Office may easily each of the business units that
Regulations share such comments with the public. implement the USPTO’s regulations, to
AGENCY: United States Patent and Electronic comments are preferred to be consider, review, and recommend ways
Trademark Office, Commerce. submitted in plain text, but also may be that the regulations could be improved,
ACTION: Notice of proposed rulemaking. submitted in ADOBE® portable revised, and streamlined. In considering
document format or MICROSOFT the revisions, the USPTO, through its
SUMMARY: The United States Patent and WORD® format. Comments not Working Group, incorporated into its
Trademark Office (USPTO or Office) submitted electronically should be analyses all presidential directives
proposes to remove its regulations submitted on paper in a format that relating to regulatory reform. The
governing reservation clauses, petitions facilitates convenient digital scanning Working Group reviewed existing
from the refusal of a primary examiner into ADOBE® portable document regulations, both discretionary and
to admit an amendment, the publication format. required by statute or judicial order. The
of amendments to the regulations, and The comments will be available for USPTO also solicited comments from
limits that the Director can impose on public inspection at the Office of the stakeholders through a web page
the number of inter partes reviews and Commissioner for Patents, currently established to provide information on
post-grant reviews heard by the Patent located in Madison East, 600 Dulany the USPTO’s regulatory reform efforts,
Trial and Appeal Board. These Street, Alexandria, Virginia. Comments and through the Department’s Federal
regulations are unnecessary or also will be available for viewing via the Register Notice titled ‘‘Impact of Federal
superfluous and in some cases have Office’s internet website (http:// Regulations on Domestic
daltland on DSKBBV9HB2PROD with PROPOSALS
expired, and their removal will help www.uspto.gov) and at http:// Manufacturing’’ (82 FR 12786, Mar. 7,
streamline USPTO’s body of regulations www.regulations.gov. Because 2017), which addressed the impact of
without reducing the availability of comments will be made available for regulatory burdens on domestic
services for the public. This proposed public inspection, information that the manufacturing. These efforts led to the
rule arises out of the USPTO’s work submitter does not desire to make development of candidate regulations
during FY 2017 to identify and propose public, such as an address or phone for removal based on the USPTO’s
regulations for removal, modification, number, should not be included in the assessment that these regulations were
and streamlining because they are comments. not needed and/or that elimination
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Document Created: 2018-01-19 02:42:41
Document Modified: 2018-01-19 02:42:41
| 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 | Notification of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by March 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-8186, [email protected] | |
| FR Citation | 83 FR 2758 |
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