Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period, 24526-24527 [2019-11012]

Download as PDF 24526 Federal Register / Vol. 84, No. 102 / Tuesday, May 28, 2019 / Notices discharge, via methods and ports compatible with required delivery dates and conditions affecting transportation known at the time of evaluation. FAR provision 52.247–51, ‘‘Evaluation of Export Offers,’’ is required for insertion in Government solicitations when supplies are to be exported through Contiguous United States (CONUS) ports and offers are solicited on a free onboard (f.o.b.) origin or f.o.b. destination basis. The provision has three alternates, to be used (1) when the CONUS ports of export are DoD water terminals, (2) when offers are solicited on an f.o.b. origin only basis, and (3) when offers are solicited on an f.o.b. destination only basis. The provision collects information regarding the offeror’s preference for delivery ports. The information is used to evaluate offers [on the basis of shipment through the port resulting in the lowest cost to the Government. C. Annual Reporting Burden Respondents: 100. Responses per Respondent: 4. Annual Responses: 400. Hours per Response: 0.25. Total Burden Hours: 100. D. Public Comment A 60-day notice published in the Federal Register at 84 FR 5084 on February 20, 2019. No comments were received. Obtaining Copies: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202–501–4755. Please cite OMB Control Number ‘‘9000–0057, Evaluation of Export Offers,’’ in all correspondence. Dated: May 21, 2019. Janet Fry, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2019–11004 Filed 5–24–19; 8:45 am] jbell on DSK3GLQ082PROD with NOTICES BILLING CODE 6820–EP–P VerDate Sep<11>2014 20:49 May 24, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–0914] Review and Update of Device Establishment Inspection Processes and Standards; 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 Agency) is extending the comment period for the notice of availability that appeared in the Federal Register on March 29, 2019. FDA requested comments on the draft guidance for industry entitled ‘‘Review and Update of Device Establishment Inspection Processes and Standards.’’ 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 March 29, 2019 (84 FR 11983). Submit either electronic or written comments on the draft guidance by June 27, 2019, 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: 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 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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– 2019–D–0914 for ‘‘Review and Update of Device Establishment Inspection Processes and Standards.’’ 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the E:\FR\FM\28MYN1.SGM 28MYN1 Federal Register / Vol. 84, No. 102 / Tuesday, May 28, 2019 / Notices 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: Tiffany Kelley, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–348–1970, Tiffany.Kelley@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register on March 29, 2019, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry entitled ‘‘Review and Update of Device Establishment Inspection Processes and Standards.’’ 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 thoughtful and detailed input. FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until June 27, 2019. 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. II. Significance of Draft Guidance FDA is issuing this draft guidance 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 this topic. 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. jbell on DSK3GLQ082PROD with NOTICES III. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information. 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 21 CFR part 803 have been approved under OMB control number 0910–0437. The collections of information in 21 CFR part 820 have VerDate Sep<11>2014 20:49 May 24, 2019 Jkt 247001 been approved under OMB control number 0910–0073. IV. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet at either https:// www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry’’ may send an email request to ORAPolicyStaffs@fda.hhs.gov to receive an electronic copy of the document. Dated: May 22, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–11012 Filed 5–24–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Medicare Rural Hospital Flexibility Program Performance, OMB No. 0915–0363—Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than June 27, 2019. ADDRESSES: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to (202) 395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information SUMMARY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 24527 Collection Clearance Officer, at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Medicare Rural Hospital Flexibility Program Performance Measures, OMB No. 0915–0363—Extension Abstract: This information collection comment request is for continued approval of the Medicare Rural Hospital Flexibility Program Performance Measures. HRSA is proposing to continue this data collection with no changes. The current performance measures are collected electronically in the Performance Improvement and Measurement System, which awardees access securely through the HRSA Electronic Handbooks. The Medicare Rural Hospital Flexibility Program (Flex Program) is authorized by Section 1820 of the Social Security Act (42 U.S.C. 1395i–4), as amended. The purpose of the Flex Program is to enable state designated entities to support critical access hospitals in quality improvement, quality reporting, performance improvement, and benchmarking; to assist facilities seeking designation as critical access hospitals; and to create a program to establish or expand the provision of rural emergency medical services. A 60-day Federal Register Notice was published in the Federal Register on February 5, 2019, vol. 84, No. 24; pp. 1751–1752. There were no public comments. Need and Proposed Use of the Information: For this program, performance measures were developed to provide data useful to the Flex program and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Modernization Act of 2010 (GPRA). These measures cover principal topic areas of interest to the Federal Office of Rural Health Policy including: (a) Quality reporting, (b) quality improvement interventions, (c) financial and operational improvement initiatives, (d) population health management, and (e) innovative care models. Several measures will be used for this program and will inform the Office’s progress toward meeting the goals set in GPRA. Furthermore, obtained information is important in identifying and understanding programmatic improvement across program areas, as well as guiding future iterations of the Flex Program and prioritizing areas of need and support. Likely Respondents: Respondents are the Flex Program coordinator for the E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Notices]
[Pages 24526-24527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11012]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0914]


Review and Update of Device Establishment Inspection Processes 
and Standards; 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 Agency) is extending 
the comment period for the notice of availability that appeared in the 
Federal Register on March 29, 2019. FDA requested comments on the draft 
guidance for industry entitled ``Review and Update of Device 
Establishment Inspection Processes and Standards.'' 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 
March 29, 2019 (84 FR 11983). Submit either electronic or written 
comments on the draft guidance by June 27, 2019, 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-2019-D-0914 for ``Review and Update of Device Establishment 
Inspection Processes and Standards.'' 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the

[[Page 24527]]

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: Tiffany Kelley, Office of Regulatory 
Affairs, Division of Operational Policy, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-348-1970, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register on March 29, 2019, FDA published a notice 
of availability with a 60-day comment period to request comments on the 
draft guidance for industry entitled ``Review and Update of Device 
Establishment Inspection Processes and Standards.''
    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 thoughtful and 
detailed input.
    FDA has considered the request and is extending the comment period 
for the notice of availability for 30 days, until June 27, 2019. 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.

II. Significance of Draft Guidance

    FDA is issuing this draft guidance 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 this topic. 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 currently approved collections of 
information. 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 21 
CFR part 803 have been approved under OMB control number 0910-0437. The 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet at either 
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Review and Update of Device Establishment 
Inspection Processes and Standards; Draft Guidance for Industry'' may 
send an email request to [email protected] to receive an 
electronic copy of the document.

    Dated: May 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11012 Filed 5-24-19; 8:45 am]
 BILLING CODE 4164-01-P

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