80 FR 37275 - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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 125 (June 30, 2015)

Page Range		37275-37276
FR Document		2015-16011

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.'' FDA is issuing this draft guidance to describe the Agency's premarket regulatory requirements and the performance testing needed to support liquid barrier claims for gowns intended for use in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 This draft guidance is being issued in light of the public health importance of personal protective equipment in health care settings and the recognition that terminology used to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 This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 80 Issue 125 (Tuesday, June 30, 2015)

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37275-37276]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-16011]

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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Use in Health Care Settings; Draft Guidance for Industry and Food and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.

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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availability of the draft guidance entitled ``Premarket Notification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 FDA is issuing this draft guidance to describe the Agency's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 This draft guidance is being issued in light of the public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 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: 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 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 ``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 http://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 http://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

37276 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices

Requirements Concerning Gowns DEPARTMENT OF HEALTH AND estimate of the burden of the proposed
Intended for Use in Health Care HUMAN SERVICES collection of information, including the
Settings’’ may send an email request to validity of the methodology and
CDRH-Guidance@fda.hhs.gov to receive National Institutes of Health assumptions used; (3) Ways to enhance
an electronic copy of the document. the quality, utility, and clarity of the
Submission for OMB Review; 60-Day information to be collected; and (4)
Please use the document number
Comment Request; Population Ways to minimize the burden of the
1500025 to identify the guidance you
Assessment of Tobacco and Health collection of information on those who
are requesting.
Study are to respond, including the use of
IV. Paperwork Reduction Act of 1995 AGENCY: National Institute on Drug appropriate automated, electronic,
Abuse (NIDA), the National Institutes of mechanical, or other technological
This guidance refers to previously
Health (NIH), Department of Health and collection techniques or other forms of
approved collections of information
Human Services. information technology.
found in FDA regulations. These
collections of information are subject to SUMMARY: In compliance with the Proposed Collection: Cognitive
review by the Office of Management and requirements of the Paperwork Interviews and Focus Groups for the
Budget (OMB) under the Paperwork Reduction Act of 1995, for opportunity Population Assessment of Tobacco and
Reduction Act of 1995 (44 U.S.C. 3501– for public comment on proposed data Health (PATH) Study (NIDA), 0925–
3520). The collections of information in collection projects, the National 0663–Revision, National Institute on
Institute on Drug Abuse (NIDA), the Drug Abuse (NIDA), National Institutes
21 CFR part 807, subparts A through D
National Institutes of Health (NIH) will of Health (NIH), in partnership with the
have been approved under OMB control
publish periodic summaries of proposed Food and Drug Administration (FDA).
number 0910–0625; the collections of
projects to be submitted to the Office of Need and Use of Information
information in 21 CFR part 807, subpart
Management and Budget (OMB) for Collection: This is a revision request
E have been approved under OMB review and approval.
control number 0910–0120; the (OMB 0925–0663, expires 11/30/2015)
DATES: Comment Due Date: Comments for the Population Assessment of
collections of information in 21 CFR
regarding this information collection are Tobacco and Health (PATH) Study to
part 803 have been approved under
best assured of having their full effect if conduct cognitive interviews and focus
OMB control number 0910–0437; the received within 60 days of the date of groups, to support the development of
collections of information in 21 CFR this publication. the Study’s questionnaires and other
part 820 have been approved under
FOR FURTHER INFORMATION CONTACT: To materials. The PATH Study is a national
OMB control number 0910–0073; and
Submit Comments and for Further longitudinal cohort study of tobacco use
the collections of information in 21 CFR Information: To obtain a copy of the behavior and health among the U.S.
part 801 have been approved under data collection plans and instruments, household population of adults age 18
OMB control number 0910–0485. submit comments in writing, or request and older and youth ages 12 to 17; the
V. Comments more information on the proposed Study conducts annual interviews and
project, contact: Dr. Kevin P. Conway, collects biospecimens from adults to
Interested persons may submit either Deputy Director, Division of inform FDA’s regulatory actions under
written comments regarding this Epidemiology, Services, and Prevention the Family Smoking Prevention and
document to the Division of Dockets Research, NIDA, NIH, 6001 Executive Control Act. Cognitive interviews and
Management (see ADDRESSES) or Boulevard, Room 5185, Rockville, MD focus groups are qualitative methods to
electronic comments to http:// 20852; or call non-toll-free number (301) assess how people interpret, process,
www.regulations.gov. It is only 443–8755 or Email your request, retrieve, and respond to phrases,
necessary to send one set of comments. including your address to: questions, response options, and
Identify comments with the docket PATHprojectofficer@mail.nih.gov. product images that may be used in the
number found in brackets in the Formal requests for additional plans and development of the PATH Study’s
heading of this document. Received instruments must be requested in questionnaires and other materials.
comments may be seen in the Division writing. These methods have previously been
of Dockets Management between 9 a.m. SUPPLEMENTARY INFORMATION: Written used to help the PATH Study improve
and 4 p.m., Monday through Friday, and comments and/or suggestions from the the comprehensibility of its materials
will be posted to the docket at http:// public and affected agencies are invited for Study participants, and to increase
www.regulations.gov. on one or more of the following points: efficiencies in data collection and
(1) Whether the proposed collection of reduce duplication and its associated
Dated: June 25, 2015.
information is necessary for the proper burden on participants and the public.
Leslie Kux,
performance of the function of the OMB approval is requested for 3
Associate Commissioner for Policy. agency, including whether the years. There are no costs to respondents
[FR Doc. 2015–16011 Filed 6–29–15; 8:45 am] information will have practical utility; other than their time. The total
BILLING CODE 4164–01–P (2) The accuracy of the agency’s annualized burden hours are 2,400.

ESTIMATED ANNUALIZED BURDEN HOURS
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Average
Number of
Number of burden per Total annual
Activity name Type of respondent responses per
respondents response burden hours
respondent (in hours)

Completing eligibility screener ...................... Youth .................................... 1,200 1 10/60 200
Adults .................................... 2,400 1 10/60 400
Examining concepts to be measured in Adults .................................... 200 1 90/60 300
PATH Study.

VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

Document Created: 2018-02-22 11:17:16
Document Modified: 2018-02-22 11:17:16

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 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.
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.
FR Citation		80 FR 37275

80 FR 37275 - Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 125 (June 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration