[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57397-57399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22646]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1038]


Over-the-Counter Ophthalmic Drug Products--Emergency Use Eyewash 
Products; Announcement of Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
hearing to obtain information on the formulation, manufacturing, and 
labeling of currently marketed over-the-counter (OTC) emergency first 
aid eyewash drug products, including the components of these products, 
and the conditions under which such products are safe and effective for 
their intended uses.
    Date and Time: The public hearing will be held on December 4, 2013, 
from 9 a.m. to 5 p.m. Submit electronic or written requests to make 
oral presentations and comments by November 13, 2013. Electronic or 
written comments will be accepted after the hearing until March 4, 
2014.
    Location: The public hearing will be held at FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Mary C. Gross, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20903, 301-796-3519, FAX: 301-847-8753, 
[email protected]; or Elaine Abraham, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20903, 301-796-0843, FAX: 301-796-9899, 
[email protected].
    Comments: Submit electronic comments 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. All comments should be identified with the docket 
number found in brackets in the heading of this document.
    Transcripts: Transcripts of the meeting will be available for 
review at the Division of Dockets Management (see Comments) and on the 
Internet at http://www.regulations.gov within 30 days of the public 
hearing. A transcript also will be available in either hard copy or on 
CD-ROM after submission of a Freedom of Information request. Written 
requests are to be sent to the Division of Freedom of Information 
(ELEM-1029), Office of Management Programs, Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Product Overview

    OTC emergency first aid eyewash drug products (EE products) are 
typically water-based solutions used in the workplace to flush or 
irrigate the eye to reduce the chance of severe injury caused by 
exposure to acid, alkali, particulate matter, or other hazardous 
materials. This public hearing will focus on EE products, including the 
components of EE products, which are marketed for use in workplace EE 
stations.
    There are two general types of EE products: Large volume and small 
volume. FDA considers ``large volume'' EE products those that provide 
sufficient fluid for 15 minutes of continuous flushing, as needed to 
satisfy the applicable performance standard for Occupational Safety and 
Health Administration (OSHA)-compliant eyewash stations (ANSI Standard 
Z 358.1). It is our current understanding that, within large-volume EE 
products, there are two general configurations currently marketed:
     Ready-to-use products that include single-use pre-filled, 
sealed wall-mount or portable eyewash stations and pre-filled, sealed 
replacement solutions, such as replacement canisters or bags, for 
refillable eyewash stations. Both sterile and nonsterile products are 
currently in the marketplace.
     Concentrated solutions and additives intended for mixing 
with potable water for use in large-volume refillable eyewash stations. 
The resulting solution is not sterile and is replaced after each use 
and at regular intervals if not used. Both sterile and nonsterile 
products are currently in the marketplace.
    Small volume EE products (16 fl. oz. to 32 fl. oz.) are marketed in 
a variety of container and applicator configurations, such as squeeze 
bottles with built-in eye cups or applicator nozzles. These small 
volume EEs are often used to deliver immediate flushing fluid prior to 
use of a large volume EE. We are interested in obtaining information on 
both the large volume and small volume EE products during this public 
meeting. Questions posed in this document regarding sterility and 
formulation are applicable to both types of EE products.
    Emergency eyewash stations using direct plumbing will not be 
considered as part of this public meeting.

B. Regulatory Background

    EE products are a type of ophthalmic drug product that FDA is 
considering for inclusion in the OTC drug monograph system. An OTC drug 
monograph is a set of FDA regulations that establish conditions of use 
(such as permitted active ingredients and required labeling) under 
which products within a given therapeutic category may be marketed 
without an approved new drug application (NDA) or abbreviated new drug 
application, based on FDA's determination that products described in 
the monograph are ``generally recognized as safe and effective'' when 
used under the conditions prescribed, recommended, or suggested in the 
product's labeling.
    FDA published a final monograph on OTC ophthalmic drug products in 
1988 (the OTC ophthalmic monograph or final monograph, 21 CFR part 
349). The final monograph defines an OTC ophthalmic drug as ``a drug 
product, which should be sterile in accordance with [21 CFR] 200.50, to 
be applied in the eyelid or instilled in the eye'' (Sec.  349.3(a) (21 
CFR 349.3(a))). ``Eyewash'' is defined in the final monograph as ``a 
sterile aqueous solution intended for washing, bathing, or flushing the 
eye'' (id. at Sec.  349.3(f)), and described in Sec.  349.20 as 
containing purified water as the active ingredient, together with 
``suitable tonicity agents to establish isotonicity with tears, 
suitable agents for establishing pH and buffering to achieve the same 
pH as tears, and a suitable preservative agent'' as inactive 
ingredients.
    The reference to sterility in Sec.  349.3(a) and (f) is based on a 
separate regulation, 21 CFR 200.50, which was adopted in 1975 and is 
applicable to all drugs intended for ophthalmic use. It states in part 
that all preparations offered or intended for ophthalmic use, including 
preparations for cleansing the eyes, should be sterile, and if they are 
not sterile may be considered adulterated and misbranded.

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    The eyewash products that are defined in and marketed under the 
final OTC ophthalmic monograph are small-volume products for non-
emergency use. The final monograph does not currently include 
conditions of use for EE products because no safety or efficacy data or 
other information were submitted on these products during the 
rulemaking process. After the final monograph was published in 1988, 
FDA received several requests from industry to clarify the regulatory 
status of EE products. In response, FDA published a request for data 
and information on these products in 1989 (call for data, 54 FR 50240 
(December 5, 1989)). In the 1989 call for data, FDA recognized the need 
for eyewash products for emergency first aid treatment of chemical 
burns (including acid and alkali burns). FDA stated in the call for 
data that these products could potentially be regulated under the OTC 
ophthalmic drug monograph and invited the submission of data and 
information to help facilitate the Agency's consideration of whether to 
amend the monograph to include these products. FDA received comments in 
response to the call for data.
    On February 19, 2003, FDA proposed to amend the final OTC 
ophthalmic drug monograph to include a section on EE products (the PR, 
68 FR 7951). The PR stated FDA's tentative conclusion that medical 
references support the safety and effectiveness of EE products to 
remove acid or alkali chemicals and that immediate flushing of the eye 
with fluid is urgently needed to lessen the impact of the chemical 
exposure.
    The PR defined EE products as ``products [that] contain water, 
agents to achieve the pH within a range of 6.6 and 7.4, and a suitable 
antimicrobial preservative agent. Additionally, they may contain 
tonicity agents to establish isotonicity with tears and agents for 
buffering the pH'' (68 FR 7951 at 7955, proposed 21 CFR 349.22). The 
proposed indication (intended use/purpose) is ``for [``flushing'' or 
``irrigating''] the eye to reduce chances of severe injury caused by 
acid, alkali, or particulate contamination.'' The PR included proposed 
warnings and directions for use for both ready-to-use EE products and 
EE products that require mixing a concentrate with potable water.
    As noted in the PR, FDA may exercise enforcement discretion to 
permit an affected OTC ophthalmic drug product that is not the subject 
of an approved NDA to be marketed until the final monograph becomes 
effective, provided the following conditions are met: (1) The product 
or similarly formulated products were marketed as OTC drugs on or 
before December 4, 1975; (2) the product does not constitute a hazard 
to health; (3) the product is not regarded as a prescription drug 
within the meaning of section 503(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(b)); and (4) the product is an OTC drug and 
does not bear claims for serious disease conditions that require the 
attention and supervision of a licensed practitioner (see 68 FR 7951 at 
7954 and 7955).
    Like all OTC drug products intended for ophthalmic use, EE products 
are subject to the general sterility requirements in 21 CFR 200.50, as 
well as general OTC drug requirements, such as drug facts labeling (21 
CFR 201.66) and compliance with current good manufacturing practices 
(21 CFR 330.1(a) and parts 210 and 211).

II. Scope of the Public Meeting

    We have reviewed the information and comments relating to EE 
products that were submitted in response to the 2003 PR, and have 
concluded that additional data and information are needed in order to 
finalize the OTC monograph with respect to EE products.
    FDA is holding this public hearing to obtain input from regulated 
industry, the medical community, consumers, and other interested 
parties concerning the formulation, manufacturing, and labeling of 
currently marketed EE drug products, including the components of such, 
and the conditions under which these products are safe and effective 
for their intended uses. Input from the public meeting will help FDA to 
establish final marketing requirements for EE products as part of the 
OTC ophthalmic drug product monograph, 21 CFR part 349.
    FDA is requesting public feedback on the following questions:
    1. What ingredients are necessary in EE formulations besides water? 
What are the functions of these other ingredients? What is the minimum 
and maximum quantity that should be allowed for these other 
ingredients?
    2. Are there any potential safety concerns or suitability issues 
with the use of ingredients other than water? What data are available 
to support the safety and suitability of EE ingredients other than 
water?
    3. What evidence supports the safety and effectiveness/suitability 
of antimicrobial preservatives when mixed with potable water to limit 
the presence of certain pathogenic microorganisms (such as 
Acanthamoeba, bacteria, or fungi)? For example, FDA is aware of 
published reports of Acanthamoeba having contaminated reservoir EE 
stations and been a source of infection in people who used these types 
of EE products (Refs. 1 and 2).
    4. Is there evidence that solutions made from EE products mixed 
with potable water are safer or more effective than potable water used 
alone? If not, what data would be needed to make that determination?
    5. What EE products or types of products are not currently 
manufactured and distributed as sterile? Are there EE products for 
which sterility is not necessary for safety? Why or why not?
    6. What directions for use are appropriate to ensure the safety and 
effectiveness of EE products for OTC use?

III. Attendance at and/or Participation in the Public Hearing

    If you wish to attend the hearing or make an oral presentation 
during the hearing, you must register by submitting an electronic 
request to: [email protected] by close of business on 
November 13, 2013. Those without email access may register by 
contacting Mary Gross or Elaine Abraham (see Contact Persons). You must 
provide your name, title, business affiliation (if applicable), 
address, email address, telephone and fax numbers, and type of 
organization you represent (e.g., industry, consumer organization) and 
a brief summary of comments, including the discussion topic(s) that 
will be addressed and the approximate time requested for your 
presentation.
    FDA will try to accommodate all persons who wish to make a 
presentation; however, the duration of each speaker's testimony may be 
limited by time constraints. FDA will notify registered presenters of 
their scheduled presentation times. Persons registered to make an oral 
presentation should check in before the hearing and are encouraged to 
arrive early to ensure their designated order of presentation. 
Participants who are not present when called risk forfeiting their 
scheduled time. An agenda of the meeting and other background material 
will be made available at least 3 days before the meeting at: http://www.fda.gov/Drugs/NewsEvents/ucm356526.htm.
    The public meeting is free and seating will be on a first-come, 
first-served basis. Early registration is recommended for those wishing 
to attend the meeting as observers or to provide testimony because 
seating is limited. FDA may limit the numbers of participants from 
individual organizations as well as total number of attendees based on 
space limitations. Registrants will receive confirmation once they have 
been accepted to attend the hearing. For those

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unable to attend in person, FDA will provide a Webcast to the meeting. 
Additional information about the Webcast location will be posted on the 
Web page, http://www.fda.gov/Drugs/NewsEvents/ucm356526.htm, prior to 
December 4, 2013.
    Any person requiring special accommodations to attend the hearing 
should direct those needs to the contact persons (see Contact Persons) 
at least 7 days in advance.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
hearing will be conducted by a presiding officer, who will be 
accompanied by FDA senior management from the Center for Drug 
Evaluation and Research.
    Under Sec.  15.30(f), the hearing is informal and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation. 
Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (21 CFR part 10, subpart C). Under 21 CFR 10.205, 
representatives of the electronic media may be permitted, subject to 
certain limitations, to videotape, film, or otherwise record FDA's 
public administrative proceedings, including presentations by 
participants. The hearing will be transcribed as stipulated in Sec.  
15.30(b) (see section III of this document for more details). To the 
extent that the conditions for the hearing as described in this 
document conflict with any provisions set out in part 15, this notice 
acts as a waiver of those provisions as specified in Sec.  15.30(h).

V. Request for Comments

    Regardless of attendance at the public hearing, interested persons 
may submit either electronic comments to http://www.regulations.gov or 
written comments to the Division of Dockets Management (see Comments). 
Persons who wish to provide additional materials for consideration 
should file these materials with the Division of Dockets Management by 
March 4, 2014. You should annotate and organize your comments to 
identify the specific questions identified by the topic to which they 
refer. It is only necessary to send one set of comments. All comment 
submissions should be marked 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.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see Comments) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

1. U.S. Environmental Protection Agency, ``Health Effects Support 
Document for Acanthamoeba,'' 2003.
2. Bowman, E. K., A. A. Vass, R. Mackowski, et al., ``Quantitation 
of Free-Living Amoebae and Bacterial Populations in Eyewash Stations 
Relative to Flushing Frequency,'' American Industrial Hygiene 
Association Journal, vol. 57, pp. 626-633, 1996.

    Dated: September 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22646 Filed 9-17-13; 8:45 am]
BILLING CODE 4160-01-P