Agency Information Collection Activities; Proposed Collection; 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, 87570-87572 [2016-29104]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 87570 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices Instructions: All submissions received must include the Docket No. FDA– 2016–N–2896 for ‘‘Public Meeting on Pre-Market Evaluation of AbuseDeterrent Properties of Opioid Drug Products; Extension of Comment Period.’’ 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 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 Division of Dockets Management. 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Silver Spring, MD 20993, 301–796– 4714, Michelle.Eby@fda.hhs.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES In the Federal Register of October 6, 2016 (81 FR 69532), FDA published a notice announcing a public meeting and requesting comments on the approach to testing FDA recommended in its draft guidance ‘‘General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products’’ 1 and FDA’s efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. The comment period ends on December 1, 2016. Because the Agency has received requests for an extension to allow interested persons additional time to submit comments, FDA is extending the comment period until January 3, 2017. Additional comments specific to the draft guidance ‘‘General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products’’ should be submitted to the docket for the draft guidance (FDA– 2016–D–0785) in lieu of, or in addition to, the docket for the public meeting. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 1, 2016. Other comments should be submitted to this docket by January 3, 2016. FDA has committed to taking steps to address the epidemic of opioid abuse transparently and in close cooperation with stakeholders and will provide other opportunities to comment, as appropriate. For example, FDA intends to issue a general guidance for public comment describing the Agency’s recommendations for standardized in vitro testing to evaluate purported abuse-deterrent properties and considerations for a potential applicant as it develops an abusedeterrent formulation of an opioid drug product. Food and Drug Administration SUPPLEMENTARY INFORMATION: Dated: November 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–29097 Filed 12–2–16; 8:45 am] BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: Michelle Eby, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6184, VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 1 http://www.fda.gov/ucm/groups/fdagov-public/ @fdagov-drugs-gen/documents/document/ ucm492172.pdf. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 [Docket No. FDA–2013–N–1089] Agency Information Collection Activities; Proposed Collection; 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 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 recommended glossary and educational outreach to support use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use. DATES: Submit either electronic or written comments on the collection of information by February 3, 2017. ADDRESSES: You may submit comments 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 E:\FR\FM\05DEN1.SGM 05DEN1 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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): 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– 2013–N–1089 for ‘‘Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.’’ 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 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 Division of Dockets Management. 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 VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 87571 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. 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 E:\FR\FM\05DEN1.SGM 05DEN1 87572 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices the specific symbols used in labels or labeling for the IVDs manufactured. 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: November 30, 2016. Leslie Kux, Associate Commissioner for Policy. collection of information to OMB for review and clearance. Medical Device: Current Good Manufacturing Practice Quality System Regulations— OMB Control Number 0910–0073—Extension [FR Doc. 2016–29104 Filed 12–2–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–2544] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 January 4, 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 0910–0073. 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, 10A63, 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 sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:12 Dec 02, 2016 Jkt 241001 Under section 520(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services has the authority to prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a device, but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to Current Good Manufacturing Practice (CGMP), as described in such regulations, to assure that the device will be safe and effective and otherwise in compliance with the FD&C Act. The CGMP/Quality System (QS) regulation implementing authority provided by this statutory provision is found under part 820 (21 CFR part 820) and sets forth basic CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. The authority for this regulation is covered under sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, and 803 of the FD&C Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383). The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/ quality problems. Requirements are compatible with specifications in the international standards ‘‘ISO 9001: Quality Systems PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Model for Quality Assurance in Design/ Development, Production, Installation, and Servicing.’’ The CGMP/QS information collections will assist FDA inspections of manufacturers for compliance with QS requirements encompassing design, production, installation, and servicing processes. Section 820.20(a) through (e) requires management with executive responsibility to establish, maintain, and/or review the following topics: (1) The quality policy, (2) the organizational structure, (3) the quality plan, and (4) the quality system procedures of the organization. Section 820.22 requires the conduct and documentation of QS audits and reaudits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training. Section 820.30(a)(1) and (b) through (j) requires, in respective order, the establishment, maintenance, and/or documentation of the following topics: (1) Procedures to control design of class III and class II devices and certain class I devices as listed therein; (2) plans for design and development activities and updates; (3) procedures identifying, documenting, and approving design input requirements; (4) procedures defining design output, including acceptance criteria, and documentation of approved records; (5) procedures for formal review of design results and documentation of results in the design history file (DHF); (6) procedures for verifying device design and documentation of results and approvals in the DHF; (7) procedures for validating device design, including documentation of results in the DHF; (8) procedures for translating device design into production specifications; (9) procedures for documenting, verifying, and validating approved design changes before implementation of changes; and (10) the records and references constituting the DHF for each type of device. Section 820.40 requires manufacturers to establish and maintain procedures controlling approval and distribution of required documents and document E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87570-87572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 recommended glossary and 
educational outreach to support use of symbols on labels and in 
labeling of in vitro diagnostic devices intended for professional use.

DATES: Submit either electronic or written comments on the collection 
of information by February 3, 2017.

ADDRESSES: You may submit comments 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

[[Page 87571]]

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): 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-2013-N-1089 for ``Recommended Glossary and Educational Outreach To 
Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic 
Devices Intended for Professional Use.'' 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 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
    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

[[Page 87572]]

the specific symbols used in labels or labeling for the IVDs 
manufactured.
    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: November 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29104 Filed 12-2-16; 8:45 am]
 BILLING CODE 4164-01-P