[Federal Register: January 7, 2011 (Volume 76, Number 5)] [Notices] [Page 1169-1170] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07ja11-65]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration[Docket No. FDA-2010-N-0492]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices:
Recommended Glossary and Educational Outreach To Support Use of Symbols
on Labels and in Labeling of In Vitro Diagnostic Devices Intended for
AGENCY: Food and Drug Administration, HHS.
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
DATES: Fax written comments on the collection of information by
February 7, 2011.
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 e-mailed to email@example.com. 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
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, e-mail: Daniel.Gittleson@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.
Medical Devices: 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)–
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
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 Act 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 will help to ensure
that IVD users will 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 number of hours per response for the
glossary and educational outreach activities were derived from
consultation with a trade association and FDA personnel. 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 October 5, 2010 (75 FR 61494), 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
Table 1–Estimated Annual Reporting Burden \1\
Section 502 of the FD&C Act/ Number of frequency per Total annual Hours per Total hours
Section 351 of the PHS Act respondents response responses response
Glossary…………………… 689 1 689 4 2,756
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
Dated: January 3, 2011.
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-74 Filed 1-6-11; 8:45 am] BILLING CODE 4160-01-P