Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Federal Register: October 5, 2010 (Volume 75, Number 192)

Notices

Page 61494-61495

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr05oc10-108

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2010-N-0492

Agency Information Collection Activities; Proposed Collection;

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 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 the reporting requirements for the collection ``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 written or electronic comments on the collection of information by December 6, 2010.

ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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,

Daniel.Gittleson@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

Page 61495

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.

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)--

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 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.

FDA estimates the burden of this collection of information as follows:

Table 1--Estimated Annual Reporting Burden\1\

Section 502 of the FD&C Act/Section 351 of the

Annual Frequency

Total Annual

Hours per

PHS Act

No. of Respondents

per Response

Responses

Response

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.

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.

Dated: September 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2010-25008 Filed 10-4-10; 8:45 am

BILLING CODE 4160-01-S