80_FR_51987 80 FR 51822 - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period

80 FR 51822 - Request for Quality Metrics; Notice of Draft Guidance Availability and Public Meeting; Request for Comments; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 165 (August 26, 2015)

Page Range51822-51823
FR Document2015-21149

The Food and Drug Administration (FDA) is extending the comment period for the notice of draft guidance availability and public meeting that appeared in the Federal Register of July 28, 2015, and August 7, 2015. In the notice of draft guidance availability and public meeting, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 80 Issue 165 (Wednesday, August 26, 2015) 
[Federal Register Volume 80, Number 165 (Wednesday, August 26, 2015)]
[Notices]
[Pages 51822-51823]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2537]


Request for Quality Metrics; Notice of Draft Guidance 
Availability and Public Meeting; Request for Comments; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of draft guidance availability and public meeting; 
request for comments; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of draft guidance availability and public 
meeting that appeared in the Federal Register of July 28, 2015, and 
August 7, 2015. In the notice of draft guidance availability and public 
meeting, FDA requested comments on a number of specific questions 
identified in the document. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the notice of draft 
guidance availability and public meeting published July 28, 2015 (80 FR 
44973) and August 7, 2015 (80 FR 47493). Submit either electronic or 
written comments by November 27, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug

[[Page 51823]]

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2015-D-2537) for this notice of draft guidance availability and 
public meeting. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lesley DeRenzo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240-
402-4612.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 28, 2015, and August 7, 2015, FDA 
published a notice of draft guidance availability and public meeting 
with a 60-day comment period and requested comments on a number of 
specific questions identified throughout the document. Comments on the 
notice of draft guidance availability and public meeting will inform 
FDA's development and planned implementation of a quality metrics 
program launched under the authority of the Federal Food, Drug, and 
Cosmetic Act.
    FDA is extending the comment period for an additional 60 days, 
until November 27, 2015. The Agency believes that an additional 60-day 
extension of the comment period for the notice of draft guidance 
availability and public meeting will allow adequate time for interested 
persons to submit comments without significantly delaying Agency 
decisionmaking on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). You should annotate and 
organize your comments to identify the specific questions or topic to 
which they refer. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

    Dated: August 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21149 Filed 8-25-15; 8:45 am]
 BILLING CODE 4164-01-P

51822 Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices injuries to the manufacturers and FDA. In the Federal Register of May 07, estimates to reflect revisions made by Importers report malfunctions only to 2015 (80 FR 26278), FDA published a the final rule, ‘‘Medical Device the manufacturers, unless they are 60-day notice requesting public Reporting: Electronic Submission unknown, then the reports are sent to comment on the proposed collection of Requirements,’’ which became effective FDA. We estimate that it will take information. No comments were August 14, 2015. respondents 0.35 hours annually to received. However, since the 60-day FDA estimates the burden of this report the information. notice, we have updated the burden collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR Section FDA Form No. responses per burden per Total hours respondents responses respondent response Exemptions—803.19 ................................ ........................ 56 4 224 1 224 User Facility Reporting—803.30 and 803.32 ................................................... ........................ 520 7 3,640 0.35 1,274 User Facility Annual Reporting—803.33 3419 520 1 520 1 520 Importer Reporting, Death and Serious Injury—803.40 and 803.42 ................... ........................ 1 1 1 1 1 Manufacturer Reporting—803.50, through 803.53 ..................................... ........................ 1,240 204 252,960 0.10 25,296 Supplemental Reports—803.56 ............... ........................ 1,050 94 98,700 0.10 9,870 Total .................................................. ........................ ........................ ........................ ........................ ........................ 37,185 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual 21 CFR Section records per burden per Total hours recordkeepers records recordkeeper recordkeeping MDR Procedures—803.17 ................................................... 1,820 1 1,820 3.3 6,006 MDR Files—803.18 .............................................................. 1,820 1 1,820 1.5 2,730 Total .............................................................................. ........................ ........................ ........................ ........................ 47,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR Section burden per Total hours respondents per disclosures disclosure respondent Importer Reporting, Malfunctions—803.40 and 803.42 ....... 60 25 1,500 0.35 525 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 20, 2015. ACTION: Notice of draft guidance availability and public meeting Leslie Kux, availability and public meeting; request published July 28, 2015 (80 FR 44973) Associate Commissioner for Policy. for comments; extension of comment and August 7, 2015 (80 FR 47493). [FR Doc. 2015–21036 Filed 8–25–15; 8:45 am] period. Submit either electronic or written BILLING CODE 4164–01–P comments by November 27, 2015. SUMMARY: The Food and Drug ADDRESSES: You may submit comments Administration (FDA) is extending the by any of the following methods: comment period for the notice of draft DEPARTMENT OF HEALTH AND Electronic Submissions guidance availability and public HUMAN SERVICES meeting that appeared in the Federal Submit electronic comments in the Food and Drug Administration Register of July 28, 2015, and August 7, following way: 2015. In the notice of draft guidance • Federal eRulemaking Portal: http:// availability and public meeting, FDA www.regulations.gov. Follow the [Docket No. FDA–2015–D–2537] requested comments on a number of instructions for submitting comments. rmajette on DSK7SPTVN1PROD with NOTICES Request for Quality Metrics; Notice of specific questions identified in the document. The Agency is taking this Written Submissions Draft Guidance Availability and Public Meeting; Request for Comments; action in response to requests for an Submit written submissions in the Extension of Comment Period extension to allow interested persons following ways: additional time to submit comments. • Mail/Hand delivery/Courier (for AGENCY: Food and Drug Administration, DATES: FDA is extending the comment paper submissions): Division of Dockets HHS. period on the notice of draft guidance Management (HFA–305), Food and Drug VerDate Sep<11>2014 14:29 Aug 25, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1

Federal Register / Vol. 80, No. 165 / Wednesday, August 26, 2015 / Notices 51823 Administration, 5630 Fishers Lane, Rm. comments to identify the specific through Building 1 where routine 1061, Rockville, MD 20852. questions or topic to which they refer. security check procedures will be Instructions: All submissions received It is only necessary to send one set of performed. For parking and security must include the Docket No. (FDA– comments. Identify comments with the information, please refer to: http:// 2015–D–2537) for this notice of draft docket number found in brackets in the www.fda.gov/AboutFDA/ guidance availability and public heading of this document. Received WorkingatFDA/BuildingsandFacilities/ meeting. All comments received may be comments may be seen in the Division WhiteOakCampusInformation/ posted without change to http:// of Dockets Management between 9 a.m. ucm241740.htm. www.regulations.gov, including any and 4 p.m., Monday through Friday, and Contact Person: Claudia Dollins, personal information provided. For will be posted to the docket at http:// Center for Devices and Radiological additional information on submitting www.regulations.gov. Health, Food and Drug Administration, comments, see the ‘‘Request for 10903 New Hampshire Ave., Bldg. 66 Dated: August 21, 2015. Comments’’ heading of the Rm. 5262, Silver Spring, MD 20993– Leslie Kux, 0002, 301–796–4807, Claudia.Dollins@ SUPPLEMENTARY INFORMATION section of Associate Commissioner for Policy. fda.hhs.gov. this document. Docket: For access to the docket to [FR Doc. 2015–21149 Filed 8–25–15; 8:45 am] Registration: Registration is free and read background documents or BILLING CODE 4164–01–P available on a first-come, first-served comments received, go to http:// basis. Persons interested in attending www.regulations.gov and insert the this public workshop must register DEPARTMENT OF HEALTH AND online by 4 p.m., October 16, 2015. docket number, found in brackets in the HUMAN SERVICES Early registration is recommended heading of this document, into the ‘‘Search’’ box and follow the prompts because facilities are limited and, Food and Drug Administration therefore, FDA may limit the number of and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. [Docket No. FDA–2015–N–2919] participants from each organization. If 1061, Rockville, MD 20852. time and space permits, onsite In Vitro Diagnostic Testing for Direct registration on the day of the public FOR FURTHER INFORMATION CONTACT: Oral Anticoagulants; Public Workshop; workshop will be provided beginning at Lesley DeRenzo, Center for Drug 8 a.m. Request for Comments Evaluation and Research, Food and Contact for Special Accommodations: Drug Administration, 10903 New AGENCY: Food and Drug Administration, If you need special accommodations Hampshire Ave., Bldg. 51, Rm. 5161, HHS. due to a disability, please contact Susan Silver Spring, MD 20993–0002, 240– ACTION: Notice of public workshop; Monahan, Center for Devices and 402–4612. request for comments. Radiological Health, Office of SUPPLEMENTARY INFORMATION: Communication and Education, 301– The Food and Drug Administration 796–5661, susan.monahan@fda.hhs.gov I. Background (FDA) is announcing a public workshop no later than October 9, 2015. In the Federal Register of July 28, entitled ‘‘In Vitro Diagnostic Testing for To register for the public workshop, 2015, and August 7, 2015, FDA Direct Oral Anticoagulants’’. The please visit FDA’s Medical Devices published a notice of draft guidance objective of the workshop is to gain News & Events—Workshops & availability and public meeting with a public input and to discuss analytical Conferences calendar at http:// 60-day comment period and requested performance requirements for the www.fda.gov/MedicalDevices/ comments on a number of specific diagnostic assessment of direct oral NewsEvents/WorkshopsConferences/ questions identified throughout the anticoagulants (DOACs) and the clinical default.htm. (Select this public document. Comments on the notice of circumstances under which patients workshop from the posted events list.) draft guidance availability and public receiving these agents would require Please provide complete contact meeting will inform FDA’s development testing. Specifically, this workshop aims information for each attendee, including and planned implementation of a to do the following: (1) Evaluate the name, title, affiliation, email, and quality metrics program launched under impact of DOACs on traditional telephone number. Those without the authority of the Federal Food, Drug, coagulation testing results; (2) identify Internet access should contact Susan and Cosmetic Act. clinical circumstances where testing of Monahan to register (see Contact for FDA is extending the comment period DOACs anticoagulant activity or Special Accommodations). Registrants for an additional 60 days, until concentration would be relevant; (3) will receive confirmation after they have November 27, 2015. The Agency discuss clinically meaningful been accepted. You will be notified if believes that an additional 60-day interpretation of coagulation testing you are on a waiting list. extension of the comment period for the results for patients on DOACs; and (4) Streaming Webcast of the Public notice of draft guidance availability and review the regulatory requirements for Workshop: This public workshop will public meeting will allow adequate time granting clearance for in vitro diagnostic also be Webcast. Persons interested in for interested persons to submit devices intended for coagulation testing viewing the Webcast must register comments without significantly in patients treated with DOACs. online by October 16, 2015. Early delaying Agency decisionmaking on Date and Time: The public workshop registration is recommended because these important issues. will be held on October 26, 2015, from Webcast connections are limited. 9 a.m. to 5 p.m. Organizations are requested to register rmajette on DSK7SPTVN1PROD with NOTICES II. Request for Comments Location: The public workshop will all participants, but to view using one Interested persons may submit either be held at FDA’s White Oak Campus, connection per location. Webcast electronic comments regarding this 10903 New Hampshire Ave., Bldg. 31 participants will be sent technical document to http://www.regulations.gov Conference Center, the Great Room (Rm. system requirements after registration or written comments to the Division of 1503), Silver Spring, MD 20993–0002. and will be sent connection access Dockets Management (see ADDRESSES). Entrance for the public meeting information after October 20, 2015. If You should annotate and organize your participants (non-FDA employees) is you have never attended a Connect Pro VerDate Sep<11>2014 14:29 Aug 25, 2015 Jkt 235001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\26AUN1.SGM 26AUN1


Document Created: 2015-12-15 10:58:31
Document Modified: 2015-12-15 10:58:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of draft guidance availability and public meeting; request for comments; extension of comment period.
DatesFDA is extending the comment period on the notice of draft guidance availability and public meeting published July 28, 2015 (80 FR 44973) and August 7, 2015 (80 FR 47493). Submit either electronic or written comments by November 27, 2015.
ContactLesley DeRenzo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5161, Silver Spring, MD 20993-0002, 240- 402-4612.
FR Citation80 FR 51822 
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