80 FR 39440 - Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 131 (July 9, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 131 (July 9, 2015)
| Page Range | 39440-39441 | |
| FR Document | 2015-16775 |
[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)] [Notices] [Pages 39440-39441] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-16775] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-2167] Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.'' This draft guidance describes FDA's intent to address the safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin United States Pharmacopeia (USP) monographs as well as outline safety testing recommendations. This draft guidance is not final nor is it in effect at this time. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 7, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for single copies of the draft guidance document entitled ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380. SUPPLEMENTARY INFORMATION: I. Background The USP \1\ heparin monographs have recently undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This draft guidance document is intended to address these safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin USP monographs (USP36-NF31),\2\ as well as outline safety testing recommendations. --------------------------------------------------------------------------- \1\ USP is a scientific nonprofit organization that develops standards for the identity, strength, quality, and purity of drugs and drug ingredients marketed in the United States. These standards are published in USP's official compendia, ``United States Pharmacopeia and National Formulary.'' \2\ USP monograph, USP PF 38 (3) and (5) Interim Revision Announcement, with proposed effective revision date of May 1, 2013. See also ``FDA Drug Safety Communication: Important Change to Heparin Container Labels to Clearly State the Total Drug Strength'' at http://www.fda.gov/Drugs/DrugSafety/ucm330695.htm. --------------------------------------------------------------------------- In addition, the outbreak of serious and often fatal events due to heparin contamination with over-sulfated chondroitin sulfate in 2008 led the USP to include in its monograph additional testing of heparin source material to ensure its quality and purity. This draft guidance also outlines use of conformance to the monograph in premarket submissions, specifically testing and documentation requirements and recommendations contained in the current USP monograph, and the guidance document ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality'' (http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory [[Page 39441]] Information/Guidances/UCM291390.pdf).\3\ --------------------------------------------------------------------------- \3\ The Agency updates guidances periodically. To make sure you have the most recent version of this guidance, check the CDER guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. --------------------------------------------------------------------------- II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on labeling and safety testing requirements for heparin-containing medical devices and combination products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it 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 downloading an electronic copy from the Internet. A search capability for all Center for Device and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1817 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations. 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 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals) have been approved under OMB control number 0910-0139. The collections of information in FDA's medical devices regulations in 21 CFR parts 801 (Labeling); 803 (Medical Device Reporting); 807, subpart E (Premarket Notification Procedures); 812 (Investigational Device Exemptions); 814, subparts A through E (Premarket Approval of Medical Devices); 814, subpart H (Humanitarian Use Devices); and 820 (Quality System Regulation) have been approved under OMB control numbers 0910-0485, 0910-0437, 0910- 0120, 0910-0078, 0910-0231, 0910-0332, and 0910-0073 respectively. V. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http://www.regulations.gov. Dated: July 2, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-16775 Filed 7-8-15; 8:45 am] BILLING CODE 4164-01-P
![39440 Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices
II. Findings and Order Dated: June 25, 2015. assist that office in processing your
Douglas Stearn, request.
Therefore, the Director, Office of Director, Division of Compliance Policy,
Enforcement and Import Operations, Submit electronic comments on the
Office of Enforcement, Office of Regulatory draft guidance to http://
Office of Regulatory Affairs, under Affairs.
www.regulations.gov. Submit written
section 306(a)(2)(B) of the FD&C Act, [FR Doc. 2015–16665 Filed 7–8–15; 8:45 am]
comments to the Division of Dockets
under authority delegated to the BILLING CODE 4164–01–P Management (HFA–305), Food and Drug
Director (Staff Manual Guide 1410.35),
Administration, 5630 Fishers Lane, Rm.
finds that Patricia Durr has been 1061, Rockville, MD 20852. Identify
convicted of a felony under federal law DEPARTMENT OF HEALTH AND
comments with the docket number
for conduct relating to the regulation of HUMAN SERVICES
found in brackets in the heading of this
a drug product. Section 306(c)(2)(A)(ii) document.
of the FD&C Act (21 U.S.C. Food and Drug Administration
335a(c)(2)(A)(ii)) requires that Ms. [Docket No. FDA–2015–D–2167] FOR FURTHER INFORMATION CONTACT:
Durr’s debarment be permanent. Angela Krueger, Center for Devices and
Heparin-Containing Medical Devices Radiological Health, Food and Drug
As a result of the foregoing findings, Administration, 10903 New Hampshire
and Combination Products:
Patricia Durr is permanently debarred Ave., Bldg. 66, Rm. 1666, Silver Spring,
Recommendations for Labeling and
from providing services in any capacity MD 20993–0002, 301–796–6380.
Safety Testing; Draft Guidance for
to a person with an approved or Industry and Food and Drug
pending drug product application under SUPPLEMENTARY INFORMATION:
Administration Staff; Availability
sections 505, 512, or 802 of the FD&C I. Background
Act (21 U.S.C. 355, 360b, or 382), or AGENCY: Food and Drug Administration,
under section 351 of the Public Health HHS. The USP 1 heparin monographs have
Service Act (42 U.S.C. 262), effective ACTION: Notice. recently undergone several revisions
(see DATES) (see section 201(dd), following serious and fatal events
306(c)(1)(B), and 306(c)(2)(A)(ii) of the SUMMARY: The Food and Drug related to the use of heparin sodium
FD&C Act (21 U.S.C. 321(dd), Administration (FDA) is announcing the products. Investigation of heparin
335a(c)(1)(B), and 335a(c)(2)(A)(ii)). Any availability of the draft guidance product overdose errors identified the
person with an approved or pending entitled ‘‘Heparin-Containing Medical expression of drug strength in the labels
Devices and Combination Products: as a major contributing factor in these
drug product application who
Recommendations for Labeling and errors. This draft guidance document is
knowingly employs or retains as a
Safety Testing.’’ This draft guidance intended to address these safety
consultant or contractor, or otherwise describes FDA’s intent to address the
uses the services of Patricia Durr, in any concerns by clarifying new expectations
safety concerns by clarifying new for labeling with regard to the soon-to-
capacity during her debarment, will be expectations for labeling with regard to
subject to civil money penalties (section be revised heparin USP monographs
the soon-to-be revised heparin United (USP36–NF31),2 as well as outline
307(a)(6) of the FD&C Act (21 U.S.C. States Pharmacopeia (USP) monographs
335b(a)(6))). If Ms. Durr provides safety testing recommendations.
as well as outline safety testing
services in any capacity to a person with recommendations. This draft guidance In addition, the outbreak of serious
an approved or pending drug product is not final nor is it in effect at this time. and often fatal events due to heparin
application during her period of contamination with over-sulfated
DATES: Although you can comment on
debarment she will be subject to civil chondroitin sulfate in 2008 led the USP
any guidance at any time (see 21 CFR
money penalties (section 307(a)(7) of the to include in its monograph additional
10.115(g)(5)), to ensure that the Agency
FD&C Act (21 U.S.C. 335b(a)(7))). In testing of heparin source material to
considers your comment on this draft
addition, FDA will not accept or review ensure its quality and purity. This draft
guidance before it begins work on the
any abbreviated new drug applications guidance also outlines use of
final version of the guidance, submit
submitted by or with the assistance of conformance to the monograph in
either electronic or written comments
Patricia Durr during her period of on the draft guidance by October 7, premarket submissions, specifically
debarment (section 306(c)(1)(A) of the 2015. testing and documentation requirements
and recommendations contained in the
FD&C Act (21 U.S.C. 335a(c)(1)(A))). ADDRESSES: An electronic copy of the current USP monograph, and the
Any application by Ms. Durr for guidance document is available for guidance document ‘‘Heparin for Drug
special termination of debarment under download from the Internet. See the and Medical Device Use: Monitoring
section 306(d)(4) of the FD&C Act (21 SUPPLEMENTARY INFORMATION section for Crude Heparin for Quality’’ (http://
U.S.C. 335a(d)(4)) should be identified information on electronic access to the www.fda.gov/downloads/Drugs/
with Docket No. FDA–2014–N–2100 guidance. Submit written requests for GuidanceComplianceRegulatory
and sent to the Division of Dockets single copies of the draft guidance
Management (see ADDRESSES). All such document entitled ‘‘Heparin-Containing 1 USP is a scientific nonprofit organization that
submissions are to be filed in four Medical Devices and Combination develops standards for the identity, strength,
copies. The public availability of Products: Recommendations for quality, and purity of drugs and drug ingredients
Labeling and Safety Testing’’ to the marketed in the United States. These standards are
srobinson on DSK5SPTVN1PROD with NOTICES
information in these submissions is published in USP’s official compendia, ‘‘United
governed by 21 CFR 10.20. Office of the Center Director, Guidance States Pharmacopeia and National Formulary.’’
and Policy Development, Center for 2 USP monograph, USP PF 38 (3) and (5) Interim
Publicly available submissions may Devices and Radiological Health, Food Revision Announcement, with proposed effective
be seen in the Division of Dockets and Drug Administration, 10903 New revision date of May 1, 2013. See also ‘‘FDA Drug
Management between 9 a.m. and 4 p.m., Safety Communication: Important Change to
Hampshire Ave., Bldg. 66, Rm. 5431, Heparin Container Labels to Clearly State the Total
Monday through Friday. Silver Spring, MD 20993–0002. Send Drug Strength’’ at http://www.fda.gov/Drugs/
one self-addressed adhesive label to DrugSafety/ucm330695.htm.
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![Federal Register / Vol. 80, No. 131 / Thursday, July 9, 2015 / Notices 39441
Information/Guidances/ Use Devices); and 820 (Quality System 5:30 p.m. Registration to attend the
UCM291390.pdf).3 Regulation) have been approved under meeting must be received by September
OMB control numbers 0910–0485, 25, 2015, at 4 p.m. See the
II. Significance of Guidance
0910–0437, 0910–0120, 0910–0078, SUPPLEMENTARY INFORMATION section for
This draft guidance is being issued 0910–0231, 0910–0332, and 0910–0073 instructions on how to register for the
consistent with FDA’s good guidance respectively. public workshop. Submit either
practices regulation (21 CFR 10.115). electronic or written comments by
The draft guidance, when finalized, will V. Comments
November 3, 2015.
represent the current thinking of FDA Interested persons may submit either ADDRESSES: The public workshop will
on labeling and safety testing electronic comments regarding this be held at the Bethesda Pooks Hill
requirements for heparin-containing document to http://www.regulations.gov Marriott, 5151 Pooks Hill Rd., Bethesda,
medical devices and combination or written comments to the Division of MD 20814. Please visit the following
products. It does not establish any rights Dockets Management (see ADDRESSES). It Web site for parking and security
for any person and is not binding on is only necessary to send one set of information: http://www.marriott.com/
FDA or the public. You can use an comments. Identify comments with the hotels/maps/travel/wasbt-bethesda-
alternative approach if it satisfies the docket number found in brackets in the marriott/.
requirements of the applicable statute heading of this document. Received Submit electronic comments to
and regulations. comments may be seen in the Division http://www.regulations.gov. Submit
III. Electronic Access of Dockets Management between 9 a.m. written comments to the Division of
and 4 p.m., Monday through Friday, and Dockets Management (HFA–305), Food
Persons interested in obtaining a copy will be posted to the docket at http://
of the draft guidance may do so by and Drug Administration, 5630 Fishers
www.regulations.gov. Lane, Rm. 1061, Rockville, MD 20852.
downloading an electronic copy from
the Internet. A search capability for all Dated: July 2, 2015. All comments should be identified with
Center for Device and Radiological Leslie Kux, the docket number found in brackets in
Health guidance documents is available Associate Commissioner for Policy. the heading of this document.
at http://www.fda.gov/MedicalDevices/ [FR Doc. 2015–16775 Filed 7–8–15; 8:45 am] FOR FURTHER INFORMATION CONTACT:
DeviceRegulationandGuidance/ BILLING CODE 4164–01–P
Hilda Scharen, Center for Devices and
GuidanceDocuments/default.htm. Radiological Health, Food and Drug
Guidance documents are also available Administration, Bldg. 66, Rm. 3625,
at http://www.regulations.gov. Persons DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave., Silver
unable to download an electronic copy HUMAN SERVICES Spring, MD 20993, 301–796–6815,
of ‘‘Heparin-Containing Medical Devices Hilda.Scharen@fda.hhs.gov; or Jamie
and Combination Products: Food and Drug Administration Waterhouse, Project Manager,
Recommendations for Labeling and [Docket No. FDA–2015–N–0001]
Neurointerventional and Neurosurgical
Safety Testing’’ may send an email Devices Branch, Division of
request to CDRH-Guidance@fda.hhs.gov Acute Ischemic Stroke Medical Neurological and Physical Medicine
to receive an electronic copy of the Devices Trials Workshop; Public Devices, Center for Devices and
document. Please use the document Workshop; Request for Comments Radiological Health, Food and Drug
number 1817 to identify the guidance Administration, 10903 New Hampshire
you are requesting. AGENCY: Food and Drug Administration, Ave., Silver Spring, MD 20993, 301–
HHS. 796–3063, Jamie.Waterhouse@
IV. Paperwork Reduction Act of 1995 ACTION: Notice of public workshop; fda.hhs.gov.
This draft guidance refers to currently request for comments. SUPPLEMENTARY INFORMATION:
approved collections of information
found in FDA regulations. These SUMMARY: The Food and Drug I. Background
collections of information are subject to Administration (FDA) is announcing the
Acute ischemic stroke medical
review by the Office of Management and following public workshop entitled
devices are intended to remove blood
Budget (OMB) under the Paperwork ‘‘Acute Ischemic Stroke Medical Device
clots from the cerebral
Reduction Act of 1995 (44 U.S.C. 3501– Trials Workshop’’. Acute ischemic
neurovasculature. This may be achieved
3520). The collections of information in stroke medical devices are intended to
through a variety of mechanisms, such
21 CFR part 211 (Current Good remove blood clots from the cerebral
as mechanical, laser, ultrasound, or a
Manufacturing Practice for Finished neurovasculature by mechanical, laser,
combination of technologies. Acute
Pharmaceuticals) have been approved ultrasound, or a combination of
ischemic stroke medical devices can
under OMB control number 0910–0139. technologies. The purpose of this
present both important safety and
The collections of information in FDA’s workshop is to obtain public input and
effectiveness questions as well as study
medical devices regulations in 21 CFR feedback on scientific, clinical, and
design and data analysis challenges.
parts 801 (Labeling); 803 (Medical regulatory considerations associated
Device Reporting); 807, subpart E with acute ischemic stroke medical II. Purpose and Scope of the Public
(Premarket Notification Procedures); devices. Ideas generated during this Workshop
812 (Investigational Device workshop may facilitate further The workshop seeks to involve
Exemptions); 814, subparts A through E development of guidance regarding the industry and academia in addressing
srobinson on DSK5SPTVN1PROD with NOTICES
(Premarket Approval of Medical content of premarket submissions for scientific, clinical, and regulatory
Devices); 814, subpart H (Humanitarian acute ischemic stroke emerging considerations associated with acute
technologies and help to speed ischemic stroke medical devices. By
3 The Agency updates guidances periodically. To development and approval of future bringing together relevant stakeholders,
make sure you have the most recent version of this submissions. which include scientists, patient
guidance, check the CDER guidance page at http://
www.fda.gov/Drugs/GuidanceCompliance DATES: The public workshop will be advocates, clinicians, researchers,
RegulatoryInformation/Guidances/default.htm. held on October 6, 2015, from 1 p.m. to industry representatives, and regulators,
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Document Created: 2018-02-23 09:14:12
Document Modified: 2018-02-23 09:14:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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 either electronic or written comments on the draft guidance by October 7, 2015. | |
| Contact | Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380. | |
| FR Citation | 80 FR 39440 |
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