Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 37275-37276 [2015-16011]

Download as PDF Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices specific BE recommendations posted on FDA’s Web site to https:// 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. The guidances, notices, and 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 https:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: June 24, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–16013 Filed 6–29–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–2261] Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.’’ FDA is issuing this draft guidance to describe the Agency’s premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. This draft guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to describe gowns has evolved, including by industry, the standards community, and health care professionals. This draft guidance is not final nor is it in effect at this time.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 asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 10.115(g)(5)), to ensure that the Agency considers your comment of 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 August 31, 2015. 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 a single hard copy of the guidance document entitled ‘‘Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings’’ 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 selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to https:// 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: Elizabeth Claverie, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993–0002, 301–796–6298. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background FDA issued a final rule on June 24, 1988 (53 FR 23874), defining ‘‘surgical apparel’’ under 21 CFR 878.4040. Under this 1988 final rule, surgical gowns and surgical masks were classified as Class II subject to premarket review under section 510(k) (21 U.S.C. 351) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), and surgical apparel other than surgical gowns and surgical masks were classified as Class I also subject to 510(k) premarket review requirements. On January 14, 2000, FDA issued a final rule (65 FR 2318) to designate as exempt from premarket notification requirements surgical apparel other than surgical gowns and surgical masks, subject to the limitations of exemptions under 21 CFR 878.9, which includes requiring a premarket notification for devices intended for a use different from the intended use of a PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 37275 legally marketed device in that generic type of device. Since the original 1988 final rule, a number of terms have been used to refer to gowns intended for use in health care settings including, but not limited to, surgical gowns, isolation gowns, surgical isolation gowns, nonsurgical gowns, procedural gowns, and operating room gowns. In 2004, FDA recognized the consensus standard American National Standards Institute/ Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003, ‘‘Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.’’ ANSI/AAMI PB 70 utilized new terminology for barrier performance of gowns. This terminology described and assessed the barrier protection levels of gowns and other protective apparel intended for use in health care facilities, by specifying test methods and performance results necessary to verify and validate the newly defined levels of barrier protection. The definitions and terminology used in this standard are inconsistent with FDA’s historical definitions of these terms and thus have added confusion in the marketplace. The purpose of this draft guidance is to clarify and describe the premarket regulatory requirements pertaining to gowns regulated under § 878.4040 and the performance testing needed to support liquid barrier claims for gowns intended for use in health care settings. 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 represents the Agency’s current thinking on performance testing to support liquid barrier claims for gowns intended for use in health care settings. 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 statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Premarket Notification E:\FR\FM\30JNN1.SGM 30JNN1 37276 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices Requirements Concerning Gowns Intended for Use in Health Care Settings’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500025 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously 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 807, subparts A through D have been approved under OMB control number 0910–0625; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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 https:// www.regulations.gov. Dated: June 25, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–16011 Filed 6–29–15; 8:45 am] BILLING CODE 4164–01–P 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Proposed Collection: Cognitive Interviews and Focus Groups for the Population Assessment of Tobacco and Health (PATH) Study (NIDA), 0925– 0663–Revision, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a revision request (OMB 0925–0663, expires 11/30/2015) for the Population Assessment of Tobacco and Health (PATH) Study to conduct cognitive interviews and focus groups, to support the development of the Study’s questionnaires and other materials. The PATH Study is a national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17; the Study conducts annual interviews and collects biospecimens from adults to inform FDA’s regulatory actions under the Family Smoking Prevention and Control Act. Cognitive interviews and focus groups are qualitative methods to assess how people interpret, process, retrieve, and respond to phrases, questions, response options, and product images that may be used in the development of the PATH Study’s questionnaires and other materials. These methods have previously been used to help the PATH Study improve the comprehensibility of its materials for Study participants, and to increase efficiencies in data collection and reduce duplication and its associated burden on participants and the public. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 2,400. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health Study National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), Department of Health and Human Services. SUMMARY: In compliance with the requirements of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Kevin P. Conway, Deputy Director, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive Boulevard, Room 5185, Rockville, MD 20852; or call non-toll-free number (301) 443–8755 or Email your request, including your address to: PATHprojectofficer@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. SUPPLEMENTARY INFORMATION: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s AGENCY: asabaliauskas on DSK5VPTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Activity name Type of respondent Completing eligibility screener ...................... Youth .................................... Adults .................................... Adults .................................... Examining concepts to be measured in PATH Study. VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 Number of responses per respondent 1,200 2,400 200 E:\FR\FM\30JNN1.SGM 1 1 1 30JNN1 Average burden per response (in hours) 10/60 10/60 90/60 Total annual burden hours 200 400 300

Agencies

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37275-37276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16011]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2261]


Premarket Notification Requirements Concerning Gowns Intended for 
Use in Health Care Settings; 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 ``Premarket Notification 
Requirements Concerning Gowns Intended for Use in Health Care 
Settings.'' FDA is issuing this draft guidance to describe the Agency's 
premarket regulatory requirements and the performance testing needed to 
support liquid barrier claims for gowns intended for use in health care 
settings. This draft guidance is being issued in light of the public 
health importance of personal protective equipment in health care 
settings and the recognition that terminology used to describe gowns 
has evolved, including by industry, the standards community, and health 
care professionals. 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 of 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 August 31, 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 a single hard copy of the guidance document entitled 
``Premarket Notification Requirements Concerning Gowns Intended for Use 
in Health Care Settings'' 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 https://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: Elizabeth Claverie, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2508, Silver Spring, MD 20993-0002, 301-
796-6298.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA issued a final rule on June 24, 1988 (53 FR 23874), defining 
``surgical apparel'' under 21 CFR 878.4040. Under this 1988 final rule, 
surgical gowns and surgical masks were classified as Class II subject 
to premarket review under section 510(k) (21 U.S.C. 351) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), and surgical apparel other 
than surgical gowns and surgical masks were classified as Class I also 
subject to 510(k) premarket review requirements. On January 14, 2000, 
FDA issued a final rule (65 FR 2318) to designate as exempt from 
premarket notification requirements surgical apparel other than 
surgical gowns and surgical masks, subject to the limitations of 
exemptions under 21 CFR 878.9, which includes requiring a premarket 
notification for devices intended for a use different from the intended 
use of a legally marketed device in that generic type of device.
    Since the original 1988 final rule, a number of terms have been 
used to refer to gowns intended for use in health care settings 
including, but not limited to, surgical gowns, isolation gowns, 
surgical isolation gowns, nonsurgical gowns, procedural gowns, and 
operating room gowns. In 2004, FDA recognized the consensus standard 
American National Standards Institute/Association of the Advancement of 
Medical Instrumentation (ANSI/AAMI) PB70:2003, ``Liquid barrier 
performance and classification of protective apparel and drapes 
intended for use in health care facilities.'' ANSI/AAMI PB 70 utilized 
new terminology for barrier performance of gowns. This terminology 
described and assessed the barrier protection levels of gowns and other 
protective apparel intended for use in health care facilities, by 
specifying test methods and performance results necessary to verify and 
validate the newly defined levels of barrier protection. The 
definitions and terminology used in this standard are inconsistent with 
FDA's historical definitions of these terms and thus have added 
confusion in the marketplace. The purpose of this draft guidance is to 
clarify and describe the premarket regulatory requirements pertaining 
to gowns regulated under Sec.  878.4040 and the performance testing 
needed to support liquid barrier claims for gowns intended for use in 
health care settings.

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 
represents the Agency's current thinking on performance testing to 
support liquid barrier claims for gowns intended for use in health care 
settings. 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 statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Premarket Notification

[[Page 37276]]

Requirements Concerning Gowns Intended for Use in Health Care 
Settings'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1500025 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously 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 807, subparts A through D 
have been approved under OMB control number 0910-0625; the collections 
of information in 21 CFR part 807, subpart E have been approved under 
OMB control number 0910-0120; the collections of information in 21 CFR 
part 803 have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to https://www.regulations.gov. 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 https://www.regulations.gov.

    Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16011 Filed 6-29-15; 8:45 am]
 BILLING CODE 4164-01-P
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