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, 3820-3821 [2014-01220]

Download as PDF 3820 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0551. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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: Application for Participation in the Medical Device Fellowship Program— (OMB Control Number 0910–0551)— (Extension) Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the Medical Device Fellowship Program will allow FDA’s Center for Devices and Radiological Health (CDRH) to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH. In the Federal Register of September 10, 2013 (78 FR 55260), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA based these estimates on the number of inquiries that have been received concerning the program and the number of requests for application forms over the past 3 years. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FDA form No. Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Application Form (Form FDA 3608) .................................... 250 1 250 1 250 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01221 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0377] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Tobacco Health Document Submission AGENCY: Food and Drug Administration, HHS. ACTION: Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01222 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Tobacco Health Document Submission’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On August 28, 2013, the Agency submitted a proposed collection of information entitled ‘‘Tobacco Health Document SUMMARY: sroberts on DSK5SPTVN1PROD with NOTICES Submission’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0654. The approval expires on December 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 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. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 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. SUMMARY: Fax written comments on the collection of information by February 24, 2014. DATES: 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, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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: E:\FR\FM\23JAN1.SGM 23JAN1 3821 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices 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 so that it is not misbranded. 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 guidance 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. Under section 502(c) of the FD&C Act, a drug or device is misbranded, ‘‘. . . If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.’’ 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 September 11, 2013 (78 FR 55724), 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: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01220 Filed 1–22–14; 8:45 am] Device Submissions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. BILLING CODE 4160–01–P FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0530] sroberts on DSK5SPTVN1PROD with NOTICES Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requests for Feedback on Medical Device Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Requests for Feedback on Medical SUMMARY: VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 On November 08, 2013, the Agency submitted a proposed collection of information entitled ‘‘Requests for Feedback on Medical Device Submissions’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0756. The approval expires on December 31, 2016. A copy of the supporting statement for this information collection is available SUPPLEMENTARY INFORMATION: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: January 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01311 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0578] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567 AGENCY: Food and Drug Administration, HHS. E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3820-3821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01220]

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

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
February 24, 2014.

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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.

[[Page 3821]]

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 so that it is not misbranded.
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 guidance 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. Under section 502(c) of the FD&C Act, a drug or device is
misbranded, ``. . . If any word, statement, or other information
required by or under authority of this chapter to appear on the label
or labeling is not prominently placed thereon with such conspicuousness
(as compared with other words, statements, designs, or devices, in the
labeling) and in such terms as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use.''
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 September 11, 2013 (78 FR 55724), 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: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01220 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P

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