83 FR 3164 - The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 15 (January 23, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 15 (January 23, 2018)
| Page Range | 3164-3165 | |
| FR Document | 2018-01122 |
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)] [Notices] [Pages 3164-3165] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01122] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-6702] The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; extension of comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 15, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry and FDA staff entitled ``The Least Burdensome Provisions: Concept and Principles.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the document published December 15, 2017 (82 FR 59623), by an additional 30 days. Submit either electronic or written comments on the draft guidance by March 15, 2018, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2017-D-6702 for ``The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.'' 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 [[Page 3165]] ``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: Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-5155; or 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: In the Federal Register of December 15, 2017, FDA published a notice of availability with a 60-day comment period to request comments on draft guidance for industry and FDA staff entitled ``The Least Burdensome Provisions: Concept and Principles.'' 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 the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act. It does not establish any rights for any person and is not binding on 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. The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response. FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until March 15, 2018. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01122 Filed 1-22-18; 8:45 am] BILLING CODE 4164-01-P
![3164 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
explain how to comply with the Dated: January 17, 2018. as a manufacturing process. Please note
requirements for hazard analysis and Leslie Kux, that if you include your name, contact
risk-based preventive controls for food Associate Commissioner for Policy. information, or other information that
for animals under part 507. The [FR Doc. 2018–01126 Filed 1–22–18; 8:45 am] identifies you in the body of your
chapters we are announcing in this BILLING CODE 4164–01–P comments, that information will be
document are as follows: posted on https://www.regulations.gov.
• If you want to submit a comment
• Introduction
DEPARTMENT OF HEALTH AND with confidential information that you
• Chapter One—The Food Safety Plan do not wish to be made available to the
HUMAN SERVICES
• Chapter Two—Conducting a Hazard public, submit the comment as a
Analysis Food and Drug Administration written/paper submission and in the
• Chapter Three—Hazards Associated [Docket No. FDA–2017–D–6702]
manner detailed (see ‘‘Written/Paper
with the Manufacturing, Processing, Submissions’’ and ‘‘Instructions’’).
Packing, and Holding of Animal Food The Least Burdensome Provisions: Written/Paper Submissions
• Chapter Four—Preventive Controls Concept and Principles; Draft
Guidance for Industry and Food and Submit written/paper submissions as
• Chapter Five—Overview of follows:
Drug Administration Staff; Availability;
Preventive Control Management • Mail/Hand delivery/Courier (for
Components Extension of Comment Period
written/paper submissions): Dockets
We intend to announce the AGENCY: Food and Drug Administration, Management Staff (HFA–305), Food and
availability for public comment of HHS. Drug Administration, 5630 Fishers
ACTION:Notice of availability; extension Lane, Rm. 1061, Rockville, MD 20852.
additional chapters of the draft guidance
of comment period. • For written/paper comments
as we complete them.
submitted to the Dockets Management
II. Significance of Guidance SUMMARY: The Food and Drug Staff, FDA will post your comment, as
Administration (FDA or the Agency) is well as any attachments, except for
This level 1 draft guidance is being extending the comment period for the information submitted, marked and
issued consistent with FDA’s good notice of availability that appeared in identified, as confidential, if submitted
guidance practices regulation (21 CFR the Federal Register of December 15, as detailed in ‘‘Instructions.’’
10.115). The draft guidance, when 2017. In the notice of availability, FDA Instructions: All submissions received
finalized, will represent the current requested comments on the draft must include the Docket No. FDA–
thinking of FDA on how to comply with guidance for industry and FDA staff 2017–D–6702 for ‘‘The Least
the hazard analysis and risk-based entitled ‘‘The Least Burdensome Burdensome Provisions: Concept and
preventive controls requirements for the Provisions: Concept and Principles.’’ Principles; Draft Guidance for Industry
regulation ‘‘Current Good The Agency is taking this action in and Food and Drug Administration
Manufacturing Practice, Hazard response to a request for an extension to Staff; Availability.’’ Received comments
Analysis, and Risk-Based Preventive allow interested persons additional time will be placed in the docket and, except
Controls for Food for Animals.’’ It does to submit comments. for those submitted as ‘‘Confidential
not establish any rights for any person DATES: FDA is extending the comment Submissions,’’ publicly viewable at
and is not binding on FDA or the public. period on the document published https://www.regulations.gov or at the
You can use an alternative approach if December 15, 2017 (82 FR 59623), by an Dockets Management Staff between 9
it satisfies the requirements of the additional 30 days. Submit either a.m. and 4 p.m., Monday through
applicable statutes and regulations. This electronic or written comments on the Friday.
guidance is not subject to Executive draft guidance by March 15, 2018, to • Confidential Submissions—To
Order 12866. ensure that the Agency considers your submit a comment with confidential
III. Paperwork Reduction Act of 1995 comment on this draft guidance before information that you do not wish to be
it begins work on the final version of the made publicly available, submit your
This draft guidance refers to guidance. comments only as a written/paper
previously approved collections of ADDRESSES: You may submit comments submission. You should submit two
information found in FDA regulations. on any guidance at any time as follows: copies total. One copy will include the
These collections of information are information you claim to be confidential
subject to review by the Office of Electronic Submissions with a heading or cover note that states
Management and Budget (OMB) under Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
the Paperwork Reduction Act of 1995 following way: CONFIDENTIAL INFORMATION.’’ The
(44 U.S.C. 3501–3520). The collections • Federal eRulemaking Portal: Agency will review this copy, including
of information in part 507 have been https://www.regulations.gov. Follow the the claimed confidential information, in
approved under OMB control number instructions for submitting comments. its consideration of comments. The
0910–0789. Comments submitted electronically, second copy, which will have the
IV. Electronic Access including attachments, to https:// claimed confidential information
www.regulations.gov will be posted to redacted/blacked out, will be available
Persons with access to the internet the docket unchanged. Because your for public viewing and posted on
may obtain the draft guidance at either comment will be made public, you are https://www.regulations.gov. Submit
sradovich on DSK3GMQ082PROD with NOTICES
https://www.fda.gov/AnimalVeterinary/ solely responsible for ensuring that your both copies to the Dockets Management
GuidanceComplianceEnforcement/ comment does not include any Staff. If you do not wish your name and
GuidanceforIndustry/default.htm or confidential information that you or a contact information to be made publicly
https://www.regulations.gov. Use the third party may not wish to be posted, available, you can provide this
FDA website listed in the previous such as medical information, your or information on the cover sheet and not
sentence to find the most current anyone else’s Social Security number, or in the body of your comments and you
version of the guidance. confidential business information, such must identify this information as
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![Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices 3165
‘‘confidential.’’ Any information marked FDA has considered the request and at the end of March 26, 2018. Comments
as ‘‘confidential’’ will not be disclosed is extending the comment period for the received by mail/hand delivery/courier
except in accordance with 21 CFR 10.20 notice of availability for 30 days, until (for written/paper submissions) will be
and other applicable disclosure law. For March 15, 2018. The Agency believes considered timely if they are
more information about FDA’s posting that a 30-day extension allows adequate postmarked or the delivery service
of comments to public dockets, see 80 time for interested persons to submit acceptance receipt is on or before that
FR 56469, September 18, 2015, or access comments without significantly date.
the information at: https://www.gpo.gov/ delaying guidance on these important
Electronic Submissions
fdsys/pkg/FR-2015-09-18/pdf/2015- issues.
23389.pdf. Submit electronic comments in the
Dated: January 17, 2018.
Docket: For access to the docket to following way:
Leslie Kux, • Federal eRulemaking Portal:
read background documents or the
Associate Commissioner for Policy. https://www.regulations.gov. Follow the
electronic and written/paper comments
received, go to https:// [FR Doc. 2018–01122 Filed 1–22–18; 8:45 am] instructions for submitting comments.
www.regulations.gov and insert the BILLING CODE 4164–01–P Comments submitted electronically,
docket number, found in brackets in the including attachments, to https://
heading of this document, into the www.regulations.gov will be posted to
‘‘Search’’ box and follow the prompts DEPARTMENT OF HEALTH AND the docket unchanged. Because your
and/or go to the Dockets Management HUMAN SERVICES comment will be made public, you are
Staff, 5630 Fishers Lane, Rm. 1061, solely responsible for ensuring that your
Food and Drug Administration comment does not include any
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2017–N–6931] confidential information that you or a
Joshua Silverstein, Center for Devices third party may not wish to be posted,
Agency Information Collection such as medical information, your or
and Radiological Health, Food and Drug
Activities; Proposed Collection; anyone else’s Social Security number, or
Administration, 10903 New Hampshire
Comment Request; Current Good confidential business information, such
Ave. Bldg. 66, Rm. 1615, Silver Spring,
Manufacturing Practices and Related as a manufacturing process. Please note
MD 20993–0002, 301–796–5155; or
Regulations for Blood and Blood that if you include your name, contact
Stephen Ripley, Center for Biologics
Components; and Requirements for information, or other information that
Evaluation and Research, Food and
Donation Testing, Donor Notification, identifies you in the body of your
Drug Administration, 10903 New
and ‘‘Lookback’’ comments, that information will be
Hampshire Ave. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240– AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
• If you want to submit a comment
402–7911. HHS.
with confidential information that you
SUPPLEMENTARY INFORMATION: In the ACTION: Notice. do not wish to be made available to the
Federal Register of December 15, 2017, public, submit the comment as a
FDA published a notice of availability SUMMARY: The Food and Drug
Administration (FDA or Agency) is written/paper submission and in the
with a 60-day comment period to manner detailed (see ‘‘Written/Paper
request comments on draft guidance for announcing an opportunity for public
comment on the proposed collection of Submissions’’ and ‘‘Instructions’’).
industry and FDA staff entitled ‘‘The
Least Burdensome Provisions: Concept certain information by the Agency. Written/Paper Submissions
and Principles.’’ Under the Paperwork Reduction Act of
Submit written/paper submissions as
This draft guidance is being issued 1995 (the PRA), Federal Agencies are
follows:
consistent with FDA’s good guidance required to publish notice in the • Mail/Hand delivery/Courier (for
practices regulation (21 CFR 10.115). Federal Register concerning each written/paper submissions): Dockets
The draft guidance, when finalized, will proposed collection of information, Management Staff (HFA–305), Food and
represent the current thinking of FDA including each proposed extension of an Drug Administration, 5630 Fishers
on the guiding principles and existing collection of information, and Lane, Rm. 1061, Rockville, MD 20852.
recommended approach for FDA staff to allow 60 days for public comment in • For written/paper comments
and industry to facilitate consistent response to the notice. This notice submitted to the Dockets Management
application of least burdensome solicits comments on the collection of Staff, FDA will post your comment, as
principles to the activities pertaining to information requirements relating to well as any attachments, except for
products meeting the statutory FDA’s regulation of current good information submitted, marked and
definition of a device regulated under manufacturing practice (CGMP) and identified, as confidential, if submitted
the Federal Food, Drug, and Cosmetic related regulations for blood and blood as detailed in ‘‘Instructions.’’
Act. It does not establish any rights for components; and requirements for Instructions: All submissions received
any person and is not binding on FDA donation testing, donor notification, and must include the Docket No. FDA–
or the public. You can use an alternative ‘‘lookback’’. 2017–N–6931 for ‘‘Current Good
approach if it satisfies the requirements DATES: Submit either electronic or Manufacturing Practices and Related
of the applicable statutes and written comments on the collection of Regulations for Blood and Blood
regulations. This draft guidance is not information by March 26, 2018. Components; and Requirements for
ADDRESSES: You may submit comments Donation Testing, Donor Notification,
sradovich on DSK3GMQ082PROD with NOTICES
subject to Executive Order 12866.
The Agency has received a request for as follows. Please note that late, and ‘Lookback’.’’ Received comments,
a 30-day extension of the comment untimely filed comments will not be those filed in a timely manner (see
period. The request conveyed concern considered. Electronic comments must ADDRESSES), will be placed in the docket
that the current 60-day comment period be submitted on or before March 26, and, except for those submitted as
does not allow sufficient time to 2018. The https://www.regulations.gov ‘‘Confidential Submissions,’’ publicly
develop a meaningful or thoughtful electronic filing system will accept viewable at https://www.regulations.gov
response. comments until midnight Eastern Time or at the Dockets Management Staff
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Document Created: 2018-01-23 01:08:54
Document Modified: 2018-01-23 01:08:54
| 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 | Notices | |
| Action | Notice of availability; extension of comment period. | |
| Dates | FDA is extending the comment period on the document published December 15, 2017 (82 FR 59623), by an additional 30 days. Submit either electronic or written comments on the draft guidance by March 15, 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 | Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301- 796-5155; or 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. | |
| FR Citation | 83 FR 3164 |
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