81_FR_18923 81 FR 18860 - Advisory Committee; Arthritis Advisory Committee, Renewal

81 FR 18860 - Advisory Committee; Arthritis Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 63 (April 1, 2016)

Page Range18860-18861
FR Document2016-07362

The Food and Drug Administration (FDA) is announcing the renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 5, 2018.

Federal Register, Volume 81 Issue 63 (Friday, April 1, 2016) 
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18860-18861]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Advisory Committee; Arthritis Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Arthritis Advisory Committee by the Commissioner of Food 
and Drugs (the Commissioner). The Commissioner has determined that it 
is in the public interest to renew the Arthritis Advisory Committee for 
an additional 2 years beyond the charter expiration date. The new 
charter will be in effect until April 5, 2018.

DATES: Authority for the Arthritis Advisory Committee will expire on 
April 5, 2018, unless the Commissioner formally determines that renewal 
is in the public interest.

FOR FURTHER INFORMATION CONTACT: Stephanie L. Begansky, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Arthritis Advisory Committee (the Committee). The 
Committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Committee advises the 
Commissioner or designee in discharging responsibilities as they relate 
to helping to ensure safe and effective drugs for human use and, as 
required, any other product for which FDA has regulatory 
responsibility. The Committee reviews and evaluates data concerning the 
safety and effectiveness of marketed and investigational human drug 
products for use in the treatment of arthritis, rheumatism, and related 
diseases, and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of arthritis, rheumatology, orthopedics, epidemiology or 
statistics, analgesics, and related specialties. Members will be 
invited to serve for overlapping terms of up to 4 years. Almost all 
non-Federal members of this committee serve as Special Government 
Employees. The core of voting members may include one technically 
qualified member, selected by the Commissioner or designee, who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the Committee may include

[[Page 18861]]

one non-voting member who is identified with industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/ucm094137.htm or by contacting the Designated Federal Officer (see FOR 
FURTHER INFORMATION CONTACT). In light of the fact that no change has 
been made to the committee name or description of duties, no amendment 
will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07362 Filed 3-31-16; 8:45 am]
 BILLING CODE 4164-01-P

18860 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices that make it ‘‘simple’’; a report description of fail-safe and failure alert statistical analyses of clinical study describing a hazard analysis that mechanisms and a description of the results. identifies potential sources of error, studies validating these mechanisms; a FDA estimates the burden of this including a summary of the design and description of clinical tests that collection of information as follows: results of flex studies and conclusions demonstrate the accuracy of the test in drawn from the flex studies; a the hands of intended operators; and TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Total Number of Total Average Number of operating and Activity responses per annual burden per Total hours respondents maintenance respondent responses response costs CLIA waiver application ........................... 40 1 40 1,200 48,000 $350,000 1 There are no capital costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Average Number of Total annual Activity records per burden per Total hours recordkeepers records recordkeeper recordkeeping CLIA waiver records ............................................................ 40 1 40 2,800 112,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The total number of reporting and DEPARTMENT OF HEALTH AND FDA is announcing the renewal of the recordkeeping hours is 160,000 hours. HUMAN SERVICES Arthritis Advisory Committee (the FDA bases the burden on an Agency Committee). The Committee is a analysis of premarket submissions with Food and Drug Administration discretionary Federal advisory clinical trials similar to the waived [Docket No. FDA–2016–N–0001] committee established to provide advice laboratory tests. Based on previous to the Commissioner. The Committee years’ experience with CLIA waiver Advisory Committee; Arthritis advises the Commissioner or designee applications, FDA expects 40 Advisory Committee, Renewal in discharging responsibilities as they manufacturers to submit one CLIA relate to helping to ensure safe and AGENCY: Food and Drug Administration, effective drugs for human use and, as waiver application per year. The time HHS. required, any other product for which required to prepare and submit a waiver application, including the time needed ACTION:Notice; renewal of advisory FDA has regulatory responsibility. The to assemble supporting data, averages committee. Committee reviews and evaluates data 1,200 hours per waiver application for SUMMARY: The Food and Drug concerning the safety and effectiveness a total of 48,000 hours for reporting. Administration (FDA) is announcing the of marketed and investigational human Based on previous years’ experience renewal of the Arthritis Advisory drug products for use in the treatment with CLIA waiver applications, FDA Committee by the Commissioner of of arthritis, rheumatism, and related expects that each manufacturer will Food and Drugs (the Commissioner). diseases, and makes appropriate spend 2,800 hours creating and The Commissioner has determined that recommendations to the Commissioner. maintaining the record for a total of it is in the public interest to renew the The Committee shall consist of a core 112,000 hours. Arthritis Advisory Committee for an of 11 voting members including the The total operating and maintenance additional 2 years beyond the charter Chair. Members and the Chair are cost associated with the waiver expiration date. The new charter will be selected by the Commissioner or application is estimated at $350,000. in effect until April 5, 2018. designee from among authorities This cost is largely attributed to clinical DATES: Authority for the Arthritis knowledgeable in the fields of arthritis, study costs incurred, which include site Advisory Committee will expire on rheumatology, orthopedics, selection and qualification, protocol April 5, 2018, unless the Commissioner epidemiology or statistics, analgesics, review, and study execution (initiation, formally determines that renewal is in and related specialties. Members will be monitoring, closeout, and clinical site/ the public interest. invited to serve for overlapping terms of subject compensation—including FOR FURTHER INFORMATION CONTACT: up to 4 years. Almost all non-Federal specimen collection for study as well as Stephanie L. Begansky, Center for Drug members of this committee serve as shipping and supplies). Evaluation and Research, Food and Special Government Employees. The Drug Administration, 10903 New core of voting members may include one asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: March 25, 2016. Hampshire Ave., Bldg. 31, Rm. 2417, technically qualified member, selected Leslie Kux, Silver Spring, MD 20993–0002, 301– by the Commissioner or designee, who Associate Commissioner for Policy. 796–9001, AAC@fda.hhs.gov. is identified with consumer interests [FR Doc. 2016–07365 Filed 3–31–16; 8:45 am] SUPPLEMENTARY INFORMATION: Pursuant and is recommended by either a BILLING CODE 4164–01–P to 41 CFR 102–3.65 and approval by the consortium of consumer-oriented Department of Health and Human organizations or other interested Services pursuant to 45 CFR part 11 and persons. In addition to the voting by the General Services Administration, members, the Committee may include VerDate Sep<11>2014 17:25 Mar 31, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1

Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18861 one non-voting member who is Electronic Submissions submission. You should submit two identified with industry interests. Submit electronic comments in the copies total. One copy will include the Further information regarding the following way: information you claim to be confidential most recent charter and other • Federal eRulemaking Portal: http:// with a heading or cover note that states information can be found at http:// www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS www.fda.gov/AdvisoryCommittees/ instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The CommitteesMeetingMaterials/Drugs/ Comments submitted electronically, Agency will review this copy, including ArthritisAdvisoryCommittee/ including attachments, to http:// the claimed confidential information, in ucm094137.htm or by contacting the www.regulations.gov will be posted to its consideration of comments. The Designated Federal Officer (see FOR second copy, which will have the the docket unchanged. Because your FURTHER INFORMATION CONTACT). In light claimed confidential information comment will be made public, you are of the fact that no change has been made redacted/blacked out, will be available solely responsible for ensuring that your to the committee name or description of for public viewing and posted on http:// comment does not include any duties, no amendment will be made to www.regulations.gov. Submit both confidential information that you or a 21 CFR 14.100. copies to the Division of Dockets third party may not wish to be posted, This document is issued under the Management. If you do not wish your such as medical information, your or Federal Advisory Committee Act (5 name and contact information to be anyone else’s Social Security number, or U.S.C. app.). For general information made publicly available, you can confidential business information, such related to FDA advisory committees, provide this information on the cover as a manufacturing process. Please note please visit us at http://www.fda.gov/ sheet and not in the body of your that if you include your name, contact AdvisoryCommittees/default.htm. comments and you must identify this information, or other information that information as ‘‘confidential.’’ Any Dated: March 25, 2016. identifies you in the body of your information marked as ‘‘confidential’’ Leslie Kux, comments, that information will be will not be disclosed except in posted on http://www.regulations.gov. Associate Commissioner for Policy. accordance with 21 CFR 10.20 and other • If you want to submit a comment [FR Doc. 2016–07362 Filed 3–31–16; 8:45 am] applicable disclosure law. For more with confidential information that you BILLING CODE 4164–01–P information about FDA’s posting of do not wish to be made available to the comments to public dockets, see 80 FR public, submit the comment as a 56469, September 18, 2015, or access DEPARTMENT OF HEALTH AND written/paper submission and in the the information at: http://www.fda.gov/ HUMAN SERVICES manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ Submissions’’ and ‘‘Instructions’’). default.htm. Food and Drug Administration Written/Paper Submissions Docket: For access to the docket to read background documents or the Submit written/paper submissions as [Docket No. FDA–2013–N–0823] electronic and written/paper comments follows: received, go to http:// Agency Information Collection • Mail/Hand delivery/Courier (for www.regulations.gov and insert the Activities; Proposed Collection; written/paper submissions): Division of docket number, found in brackets in the Comment Request; Format and Dockets Management (HFA–305), Food heading of this document, into the Content Requirements for Over-the- and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Counter Drug Product Labeling Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets • For written/paper comments Management, 5630 Fishers Lane, Rm. AGENCY: Food and Drug Administration, submitted to the Division of Dockets 1061, Rockville, MD 20852. HHS. Management, FDA will post your comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: FDA ACTION: Notice. PRA Staff, Office of Operations, Food except for information submitted, marked and identified, as confidential, and Drug Administration, 8455 SUMMARY: The Food and Drug Colesville Rd., COLE–14526, Silver Administration (FDA) is announcing an if submitted as detailed in ‘‘Instructions.’’ Spring, MD 20993–0002, PRAStaff@ opportunity for public comment on the fda.hhs.gov. proposed collection of certain Instructions: All submissions received information by the Agency. Under the must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (the 2013–N–0823 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal PRA), Federal Agencies are required to Collection Activities; Proposed Agencies must obtain approval from the publish notice in the Federal Register Collection; Comment Request; Format Office of Management and Budget concerning each proposed collection of and Content Requirements for Over-the- (OMB) for each collection of information, including each proposed Counter Drug Product Labeling.’’ information they conduct or sponsor. extension of an existing collection of Received comments will be placed in ‘‘Collection of information’’ is defined information, and to allow 60 days for the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR public comment in response to the submitted as ‘‘Confidential 1320.3(c) and includes Agency requests notice. This notice solicits comments on Submissions,’’ publicly viewable at or requirements that members of the http://www.regulations.gov or at the public submit reports, keep records, or asabaliauskas on DSK3SPTVN1PROD with NOTICES the standardized format and content requirements for the labeling of over- Division of Dockets Management provide information to a third party. the-counter (OTC) drug products. between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44 through Friday. U.S.C. 3506(c)(2)(A)) requires Federal DATES: Submit either electronic or • Confidential Submissions—To Agencies to provide a 60-day notice in written comments on the collection of submit a comment with confidential the Federal Register concerning each information by May 31, 2016. information that you do not wish to be proposed collection of information, ADDRESSES: You may submit comments made publicly available, submit your including each proposed extension of an as follows: comments only as a written/paper existing collection of information, VerDate Sep<11>2014 19:10 Mar 31, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\01APN1.SGM 01APN1


Document Created: 2016-04-06 00:08:42
Document Modified: 2016-04-06 00:08:42
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; renewal of advisory committee.
DatesAuthority for the Arthritis Advisory Committee will expire on April 5, 2018, unless the Commissioner formally determines that renewal is in the public interest.
ContactStephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, [email protected]
FR Citation81 FR 18860 
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