Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 13813-13814 [2017-05106]

Download as PDF Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices will provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using medical devices and radiation-emitting products by providing users with a better context in which to place risk information more completely. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the developmental stage. Respondents will be asked to give their reaction to the messages in either individual or group settings. Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution method of these messages in achieving the objectives of the message campaign. Evaluation of campaigns is a vital link in continuous improvement of communications at FDA. Annually, FDA projects about 30 studies using a variety of research methods and lasting an average of 0.17 hours each (varying from 0.08 to 1.5 13813 hours). FDA estimates the burden of this collection of information based on prior recent experience with the various types of data collection methods described earlier. FDA is requesting this burden so as not to restrict the Agency’s ability to gather information on public sentiment for its proposals in its regulatory and communications programs. In the Federal Register of October 28, 2016 (81 FR 75134), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours Individual in-depth interviews ....................................... General public focus group interviews ......................... Intercept interviews: Central location ........................... Intercept interviews: Telephone ................................... Self-administered surveys ............................................ Gatekeeper reviews ..................................................... Omnibus surveys .......................................................... 360 144 200 4,000 2,400 400 1,200 1 1 1 1 1 1 1 360 144 200 4,000 2,400 400 1,200 .75 (45 minutes) .... 1.5 ......................... .25 (15 minutes) .... .08 (5 minutes) ...... .25 (15 minutes) .... .5 (30 minutes) ...... .17 (10 minutes) .... 270 216 50 320 600 200 204 Total (general public) ............................................ 8,704 ........................ ........................ ............................... 1,860 Physician focus group interviews ................................. 144 1 144 1.5 ......................... 216 Total (physician) .................................................... 144 ........................ ........................ ............................... 216 Total (overall) ................................................. 8,848 ........................ ........................ ............................... 2,076 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 14, 2017. [FR Doc. 2017–05097 Filed 3–14–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration asabaliauskas on DSK3SPTVN1PROD with NOTICES2 [Docket No. FDA–2013–N–1089] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing SUMMARY: VerDate Sep<11>2014 18:19 Mar 14, 2017 Jkt 241001 To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: (202) 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0553. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use OMB Control Number 0910–0553— Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements for the label or labeling of a medical device to avoid misbranding. Section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262) establishes requirements that manufacturers of biological products must submit a license application for FDA review and approval prior to marketing a biological product for introduction into interstate commerce. E:\FR\FM\15MRN1.SGM 15MRN1 13814 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices In the Federal Register of November 30, 2004 (69 FR 69606), FDA published a notice of availability of the guidance entitled ‘‘Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.’’ The document provides guidance for the voluntary use of selected symbols in place of text in labeling. It provides the labeling guidance required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10, FDA’s labeling requirements for IVDs; and (2) FDA’s labeling requirements for biologics, including IVDs under 21 CFR parts 610 and 660. The guidance document recommends that a glossary of terms accompany each IVD to define the symbols used on that device’s labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information help to ensure that IVD users have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the labeling requirements under section 502(c) of the FD&C Act and section 351 of the PHS Act. The likely respondents for this collection of information are IVD manufacturers who plan to use the selected symbols in place of text on the labels and/or labeling of their IVDs. The glossary activity is inclusive of both domestic and foreign IVD manufacturers. FDA receives submissions from approximately 689 IVD manufacturers annually. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary for the specific symbols used in labels or labeling for the IVDs manufactured. In the Federal Register of December 5, 2016 (81 FR 87570), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Glossary ............................................................................... 689 1 689 4 2,756 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. solicits comments on the Safety Communication Readership Survey. DATES: Submit either electronic or written comments on the collection of information by May 15, 2017. ADDRESSES: You may submit comments as follows: [FR Doc. 2017–05106 Filed 3–14–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions Food and Drug Administration [Docket No. FDA–2009–N–0360] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey 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 (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 asabaliauskas on DSK3SPTVN1PROD with NOTICES2 SUMMARY: VerDate Sep<11>2014 18:19 Mar 14, 2017 Jkt 241001 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 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2009–N–0360 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey.’’ 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 Division of Dockets Management 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 E:\FR\FM\15MRN1.SGM 15MRN1

Agencies

[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13813-13814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05106]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1089]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommended Glossary 
and Educational Outreach To Support Use of Symbols on Labels and in 
Labeling of In Vitro Diagnostic Devices Intended for Professional Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
14, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: (202) 395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0553. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Recommended Glossary and Educational Outreach To Support Use of Symbols 
on Labels and in Labeling of In Vitro Diagnostic Devices Intended for 
Professional Use

OMB Control Number 0910-0553--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 352), among other things, establishes requirements for 
the label or labeling of a medical device to avoid misbranding. Section 
351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262) 
establishes requirements that manufacturers of biological products must 
submit a license application for FDA review and approval prior to 
marketing a biological product for introduction into interstate 
commerce.

[[Page 13814]]

    In the Federal Register of November 30, 2004 (69 FR 69606), FDA 
published a notice of availability of the guidance entitled ``Use of 
Symbols on Labels and in Labeling of In Vitro Diagnostic Devices 
Intended for Professional Use.'' The document provides guidance for the 
voluntary use of selected symbols in place of text in labeling. It 
provides the labeling guidance required for: (1) In vitro diagnostic 
devices (IVDs), intended for professional use under 21 CFR 809.10, 
FDA's labeling requirements for IVDs; and (2) FDA's labeling 
requirements for biologics, including IVDs under 21 CFR parts 610 and 
660.
    The guidance document recommends that a glossary of terms accompany 
each IVD to define the symbols used on that device's labels and/or 
labeling. Furthermore, the guidance recommends an educational outreach 
effort to enhance the understanding of newly introduced symbols. Both 
the glossary and educational outreach information help to ensure that 
IVD users have enough general familiarity with the symbols used, as 
well as provide a quick reference for available materials, thereby 
further ensuring that such labeling satisfies the labeling requirements 
under section 502(c) of the FD&C Act and section 351 of the PHS Act.
    The likely respondents for this collection of information are IVD 
manufacturers who plan to use the selected symbols in place of text on 
the labels and/or labeling of their IVDs.
    The glossary activity is inclusive of both domestic and foreign IVD 
manufacturers. FDA receives submissions from approximately 689 IVD 
manufacturers annually. The 4-hour estimate for a glossary is based on 
the average time necessary for a manufacturer to modify the glossary 
for the specific symbols used in labels or labeling for the IVDs 
manufactured.
    In the Federal Register of December 5, 2016 (81 FR 87570), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Glossary...........................................................             689                1              689                4            2,756
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05106 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P
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