The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period, 3164-3165 [2018-01122]

Download as PDF 3164 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices explain how to comply with the requirements for hazard analysis and risk-based preventive controls for food for animals under part 507. The chapters we are announcing in this document are as follows: • Introduction • Chapter One—The Food Safety Plan • Chapter Two—Conducting a Hazard Analysis • Chapter Three—Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food • Chapter Four—Preventive Controls • Chapter Five—Overview of Preventive Control Management Components We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them. This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on how to comply with the hazard analysis and risk-based preventive controls requirements for the regulation ‘‘Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.’’ 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 guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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). The collections of information in part 507 have been approved under OMB control number 0910–0789. sradovich on DSK3GMQ082PROD with NOTICES IV. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. 17:59 Jan 22, 2018 [FR Doc. 2018–01126 Filed 1–22–18; 8:45 am] BILLING CODE 4164–01–P 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. Notice of availability; extension of comment period. ACTION: 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: SUMMARY: II. Significance of Guidance VerDate Sep<11>2014 Dated: January 17, 2018. Leslie Kux, Associate Commissioner for Policy. Jkt 244001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 E:\FR\FM\23JAN1.SGM 23JAN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices ‘‘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/201523389.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. VerDate Sep<11>2014 17:59 Jan 22, 2018 Jkt 244001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6931] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘‘Lookback’’ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information requirements relating to FDA’s regulation of current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donation testing, donor notification, and ‘‘lookback’’. DATES: Submit either electronic or written comments on the collection of information by March 26, 2018. 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 March 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 3165 at the end of March 26, 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–6931 for ‘‘Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘Lookback’.’’ 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 E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3164-3165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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, 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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.