Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability, 31615-31616 [2011-13390]

Download as PDF 31615 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Notices during site visits), and as a support for management decision making. Respondents: 55 State Developmental Disabilities Councils. Number of respondents Instrument Number of responses per respondent 55 1 State Developmental Disabilities Council 5-Year State Plan .......................................... Estimated Total Annual Burden Hours: 20,185 Additional Information Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285. E-mail: oira_submission@omb.eop.gov, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2011–13416 Filed 5–31–11; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration mstockstill on DSK4VPTVN1PROD with NOTICES [Docket No. FDA–2011–D–0305] Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance SUMMARY: VerDate Mar<15>2010 18:48 May 31, 2011 Jkt 223001 Annual Burden Estimates entitled ‘‘Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.’’ This draft guidance document is intended for manufacturers and distributors of research use only (RUO) and investigational use only (IUO) in vitro diagnostic (IVD) products and any other entities who label IVD products. DATES: 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 written or electronic comments on the draft guidance by August 30, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Commercially Distributed in Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 or Office of Communication, Outreach and Development (HFM–40), 1401 Rockville Pike, suite 200N, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to CDRH at 301–847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Tonya Wilbon, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 66, rm. 5663, Silver Spring, MD 20993–0002, 301–796–6224. FOR QUESTIONS RELATING TO DEVICES REGULATED BY CBER, CONTACT: Stephen PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Average burden hours per response 367 Total burden hours 20,185 Ripley (HFM–17), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852– 1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background RUO and IUO IVD products are distinctive in that they are devices that may themselves be used in research or investigations on human samples that may eventually lead to their clearance or approval for clinical diagnostic use, and they also may be marketed for and used in the research and investigation of other FDA-regulated products. Thus, the manufacturer of an IUO IVD product is not necessarily the sponsor of a clinical investigation that uses such an IVD product in a study. The manufacturer of such an IUO IVD product may legally distribute the product commercially without FDA premarket review, as long as the marketing is only for investigational use. The marketing of unapproved and uncleared IVD products for purposes other than research or investigation (for example, for clinical diagnostic use) has led in some cases to diagnostic use of laboratory tests with unproven performance characteristics and manufacturing controls that are inadequate to ensure consistent manufacturing of the finished product. Use of such tests for clinical diagnostic purposes may mislead healthcare providers and cause serious adverse health consequences to patients who are not aware that they are being diagnosed with research or investigational products. FDA is therefore issuing this guidance to remind manufacturers of the requirements applicable to RUO and IUO IVDs. This guidance will clarify the regulatory requirements applicable to IVD products intended for research use only or investigational use only and will provide the responses of CDRH and CBER to some frequently asked questions about how products should and should not be marketed. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance E:\FR\FM\01JNN1.SGM 01JNN1 31616 Federal Register / Vol. 76, No. 105 / Wednesday, June 1, 2011 / Notices practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the Agency’s current thinking on ’’ Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov or from the CBER Internet site at https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm. To receive ’’ Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions,’’ you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1723 to identify the guidance you are requesting. mstockstill on DSK4VPTVN1PROD with NOTICES IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations and guidance documents. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 809.10 have been approved under OMB control number 0910–0485; the collections in 21 CFR part 812 have been approved under OMB control number 0910–0078; and the collections of information regarding importer entry notice have been approved under OMB control number 0910–0046. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket VerDate Mar<15>2010 18:48 May 31, 2011 Jkt 223001 number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 18, 2011. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2011–13390 Filed 5–31–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing Public Health Service, National Institutes of Health, HHS. ACTION: Notice. AGENCY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. SUMMARY: Thrombolytic Temperature-Sensitive Liposomes Description of Technology: The subject technology discloses a novel method for inducing targeted thrombolysis in blood vessels. In this technology, a thrombolytic agent is encapsulated within temperaturesensitive liposomes. This composition is administered into the patient’s blood circulation. Certain clots and vulnerable atherosclerotic processes elicit an endogenous heat that facilitates local thrombolytic drug release. The thermosensitive liposome can also be exogenously heated to at least its phase transition temperature to induce the release the thrombolytic agent from the liposome at the thrombus for targeted PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 thrombolysis. The temperature for activated release can be varied, depending on the specific composition of the liposome. Applications: Thrombolysis of blood clots formed in blood vessels, primarily in thromboemblic diseases such as myocardial infarction and stroke, venous thromboemblic diseases such as deep vein thrombosis (DVT), and pulmonary embolism (PE). Advantages: • Due to the protection of the thrombolytic agent within the liposome structure until the time that release is induced, this technology provides for better stability and longer half-life of the agent. —Enhanced efficacy compared to the currently used thrombolytic treatments. —Decreased side effects compared to the currently used thrombolytic treatments. —Potentially decreased immunogenicity. • Lower treatment dose may be required compared to current methods using free thrombolytic agent. —Increases safety profile and reduces the risk of dose-related intracranial hemorrhage in treated patients. Development Status: Proof of principle has been demonstrated in vitro. Inventors: Bradford Wood, Matt Dreher, et al. (NIHCC). Patent Status: U.S. Provisional Application No. 61/473,665 filed 08 Apr 2011 (HHS Reference No. E–090–2011/ 0–US–01). Relevant Publications: 1. Collen D. Staphylokinase: A potent, uniquely fibrin-selective thrombolytic agent. Nat Med. 1998 Mar;4(3):279–284. [PMID: 9500599] 2. Elbayoumi TA, Torchilin VP. Liposomes for targeted delivery of antithrombotic drugs. Expert Opin Drug Deliv. 2008 Nov;5(11):1185–1198. [PMID: 18976130] 3. Heeremans JL, Prevost R, Bekkers ME, et al. Thrombolytic treatment with tissue-type plasminogen activator (t-PA) containing liposomes in rabbits: A comparison with free t-PA. Thromb Haemost. 1995;73(3):488–494. [PMID: 7667833] 4. Tiukinhoy-Laing SD, Huang S, Klegerman M, Holland CK, McPherson DD. Ultrasound-facilitated thrombolysis using tissue-plasminogen activatorloaded echogenic liposomes. Thromb Res. 2007;119(6):777–784. [PMID: 16887172] 5. Needham D, Dewhirst MW. The development and testing of a new temperature sensitive drug delivery E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 76, Number 105 (Wednesday, June 1, 2011)]
[Notices]
[Pages 31615-31616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13390]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0305]


Draft Guidance for Industry and FDA Staff: Commercially 
Distributed In Vitro Diagnostic Products Labeled for Research Use Only 
or Investigational Use Only: Frequently Asked Questions; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Commercially Distributed 
In Vitro Diagnostic Products Labeled for Research Use Only or 
Investigational Use Only: Frequently Asked Questions.'' This draft 
guidance document is intended for manufacturers and distributors of 
research use only (RUO) and investigational use only (IUO) in vitro 
diagnostic (IVD) products and any other entities who label IVD 
products.

DATES: 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 written or electronic comments on the draft guidance 
by August 30, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Commercially Distributed in Vitro 
Diagnostic Products Labeled for Research Use Only or Investigational 
Use Only: Frequently Asked Questions'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 or 
Office of Communication, Outreach and Development (HFM-40), 1401 
Rockville Pike, suite 200N, Rockville, MD 20852. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to CDRH at 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to https://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Tonya Wilbon, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg 66, rm. 5663, Silver Spring, MD 20993-0002, 301-796-6224.

FOR QUESTIONS RELATING TO DEVICES REGULATED BY CBER, CONTACT: Stephen 
Ripley (HFM-17), Center for Biologics Evaluation and Research, Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    RUO and IUO IVD products are distinctive in that they are devices 
that may themselves be used in research or investigations on human 
samples that may eventually lead to their clearance or approval for 
clinical diagnostic use, and they also may be marketed for and used in 
the research and investigation of other FDA-regulated products. Thus, 
the manufacturer of an IUO IVD product is not necessarily the sponsor 
of a clinical investigation that uses such an IVD product in a study. 
The manufacturer of such an IUO IVD product may legally distribute the 
product commercially without FDA premarket review, as long as the 
marketing is only for investigational use.
    The marketing of unapproved and uncleared IVD products for purposes 
other than research or investigation (for example, for clinical 
diagnostic use) has led in some cases to diagnostic use of laboratory 
tests with unproven performance characteristics and manufacturing 
controls that are inadequate to ensure consistent manufacturing of the 
finished product. Use of such tests for clinical diagnostic purposes 
may mislead healthcare providers and cause serious adverse health 
consequences to patients who are not aware that they are being 
diagnosed with research or investigational products. FDA is therefore 
issuing this guidance to remind manufacturers of the requirements 
applicable to RUO and IUO IVDs.
    This guidance will clarify the regulatory requirements applicable 
to IVD products intended for research use only or investigational use 
only and will provide the responses of CDRH and CBER to some frequently 
asked questions about how products should and should not be marketed.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance

[[Page 31616]]

practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the Agency's current thinking on '' 
Commercially Distributed In Vitro Diagnostic Products Labeled for 
Research Use Only or Investigational Use Only: Frequently Asked 
Questions.'' It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov or from the 
CBER Internet site at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive '' 
Commercially Distributed In Vitro Diagnostic Products Labeled for 
Research Use Only or Investigational Use Only: Frequently Asked 
Questions,'' you may either send an e-mail request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1723 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. These 
collections of information are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
809.10 have been approved under OMB control number 0910-0485; the 
collections in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; and the collections of information regarding importer 
entry notice have been approved under OMB control number 0910-0046.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 18, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-13390 Filed 5-31-11; 8:45 am]
BILLING CODE 4160-01-P
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