
[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29275-29277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1092]


Over-the-Counter Monograph User Fees: Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to gather stakeholder input on the potential development of a 
user-fee program for nonprescription (over-the-counter or OTC) 
monograph drugs. A user-fee program would provide funding to supplement 
congressional non-user-fee appropriations, and would support timely and 
efficient FDA review of the efficacy and safety of ingredients included 
in or proposed for inclusion in a monograph. FDA invites public comment 
on a potential OTC monograph user-fee program and also invites 
suggestions regarding the features such a user-fee program should 
include.

DATES: The public meeting will be held on Friday, June 10, 2016, from 9 
a.m. to 5 p.m. EDT. However, depending on the level of public 
participation, the meeting may be extended or may end early.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
Bldg. 31 Conference Center, 10903 New Hampshire Ave., the Great Room 
(Rm. 1503A), 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 refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.
    Comments: Regardless of participation at the public meeting, 
interested persons may submit electronic or written comments regarding 
this document. To provide adequate time for parties to submit comments 
before and after the public meeting, the docket will remain open 30 
days after the public meeting.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1092 for ``Over-the-Counter Monograph User Fees: Public 
Meeting; Requests for Comments.'' Received comments will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://

[[Page 29276]]

www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amy Bertha, Office of Executive 
Programs, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 
301-796-1647, email: OTCMonographUserFeeProgram@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public meeting to obtain input on a potential 
OTC monograph user-fee program. The Prescription Drug User Fee Act 
(PDUFA) and other FDA user-fee programs for medical products provide 
vital resources that have enabled more timely evaluation of the safety 
and efficacy of many prescription drugs, biologics and devices, with 
consequent benefits to public health through the expanded availability 
of products to treat and manage a wide variety of conditions. However, 
no user-fee program exists for hundreds of thousands of drug products 
marketed under OTC drug monographs. Millions of American consumers 
every year use monograph drug products to self-manage numerous 
conditions. The efficacy and safety of these drugs is important to 
public health, but FDA is critically under-resourced in this regulatory 
area.
    In the United States, OTC drugs are marketed in two different 
ways--under an approved marketing application (new drug application 
(NDA) or abbreviated new drug application (ANDA)) or under the OTC 
monograph system, which was set up to review the safety and efficacy of 
drug products that were marketed OTC in the United States prior to the 
current statutory NDA process. When sponsors submit marketing 
applications, FDA reviews these applications and approves those drugs 
that are found to be safe and effective under their proposed conditions 
of use with benefits that outweigh their risks. However, at the time of 
establishment of the statutory efficacy requirement, there were 
hundreds of thousands of OTC products on the market. Withdrawing all 
those products and requiring submission of a new drug application for 
each one was undesirable for public health, and would have resulted in 
an overwhelming number of individual applications for review. Instead, 
in 1972, FDA established the OTC drug review process. In that process, 
expert advisory review panels were established to evaluate evidence of 
safety and efficacy for ingredients in broad therapeutic classes of OTC 
drug products. These panels reviewed data submissions and provided 
reports to FDA. Those reports made recommendations regarding whether or 
not the ingredients were ``generally recognized as safe and effective 
(GRASE)'' for use in self-treatment. The review panels also reviewed 
claims and recommended appropriate labeling. Based on the panels' 
reviews, FDA published in the Federal Register advanced notices of 
proposed rulemaking and, after additional Agency review and public 
comment, tentative final monographs. Subsequently, final regulations in 
the form of individual drug monographs were established for various 
therapeutic areas; these monographs establish conditions of use under 
which ingredients are considered GRASE for inclusion in an OTC drug. 
Conditions of use can include, for example, indications for use, dosage 
form, and route of administration. Products that conform to all 
applicable regulations, including all aspects of the relevant 
monograph, will be GRASE and not misbranded if marketed without an 
approved marketing application. GRASE determinations were made, and 
monographs proposed and finalized, for many ingredients for many drug 
products. However, the process has not been completed for all 
ingredients, nor for all OTC conditions of use. In many cases, the data 
submitted to the advisory panels were inadequate for a final GRASE 
determination; these ingredients are referred to as ``Category III'' 
ingredients in OTC products. Many products containing Category III 
ingredients without a GRASE determination continue to be marketed. By 
contrast, ingredients with a final determination of ``not GRASE'' need 
an approved marketing application to be legally marketed.
    The OTC monograph drug review process remains one of the largest 
and most complex regulatory programs ever undertaken at FDA. There are 
approximately 88 simultaneous rulemakings in 26 broad therapeutic areas 
encompassing hundreds of thousands of products. There are approximately 
800 active ingredients for over 1,400 different therapeutic uses. FDA 
needs additional resources to work toward finalization of the monograph 
review process and to address safety issues in a more efficient and 
timely manner. Additional resources would also better enable the Agency 
to consider innovations for drug products containing monograph 
ingredients, such as the development of new dosage forms for 
ingredients under existing monographs.
    There are some important differences between marketing through 
approved applications and marketing under the monographs. NDAs and 
ANDAs are product-based; an application typically is submitted with 
data for a single drug product to be marketed by a single sponsor, and 
that application will be approved or not approved. By contrast, the 
monograph system is ingredient-based; numerous sponsors may make the 
same ingredient for the same use, and all may market drug products made 
with this ingredient as long as they comply with all applicable 
regulations, including the conditions of the monograph. Sponsors of 
monograph drugs are not required to seek FDA approval prior to 
marketing a product under the monograph. In addition, the monograph 
system, where ingredients are determined to be GRASE or not, is a 
public process. Data are submitted to public dockets, and anyone may 
provide input. By contrast, while FDA typically makes NDA information 
public after approval of a product, it generally cannot do so before.
    At this time, once a monograph has been established, additional 
rulemaking is required for changes to that monograph. FDA is working on 
multiple policy reforms to streamline and modernize the monograph 
system; those policy reforms are not the topic of this public meeting. 
Funds from other user-fee programs cannot be used to fund monograph 
activities, and FDA receives

[[Page 29277]]

very few resources that it can allocate to monograph review work.
    The potential benefits of additional resources from a monograph 
user-fee program include benefits to public health and sponsors of 
monograph drug products, such as the following:
     Ability to address safety issues of currently marketed 
products in an efficient and timely manner.
     Timely determination on the safety and efficacy of 
monograph ingredients under the conditions of the monograph, helping to 
assure appropriate marketing of thousands of nonprescription products 
used daily by U.S. consumers.
     Increased availability of certain monograph product 
innovations proposed by industry.
     Streamlined ability to update monographs to allow modern 
testing methods in several areas, potentially reducing the need for 
animal testing, and simplifying and speeding product development.
     Development of information technology infrastructure to 
speed numerous parts of the monograph review process, and enable a 
modern robust system for submission of materials and archiving of 
documents.
     Development of a modern, useful, and transparent FDA 
monograph Web site to provide the public and industry with access to 
important information.
     Ability to hold more public meetings on important 
monograph issues.
     Increased ability of FDA to respond to monograph-related 
concerns and questions from the public and industry.
     Establishment of additional infrastructure for the 
efficient continued conduct of monograph activities in the longer term.

II. Purpose of Public Meeting

    The purpose of the meeting is to obtain input from industry and 
other interested stakeholders regarding a potential OTC monograph user-
fee program. There are several factors that FDA considers important in 
developing a user-fee program. First, to achieve a program's goals of 
efficient and timely oversight of a category of products, FDA must be 
able to rely on a stable and predictable source of adequate funding. 
Funding sources that result in unpredictable revenue cause uncertainty 
about FDA's ability to continue supporting activities over time which 
disrupts the Agency's regulatory operations and contributes to 
difficulties in conducting long-range planning. Second, the assessment 
of fees can create certain incentives or disincentives for the activity 
that is the subject of the fee. For example, a sponsor who currently 
has an unmarketed product has an incentive to pay a fee to seek FDA 
approval to market the product. However, once the product is approved 
and marketed, there is less incentive to pay a fee for additional 
specific activities regarding the product that are otherwise not 
required. If those activities are important from a public health 
perspective, assessing a fee for them would be undesirable because the 
fee could discourage entities to undertake those activities. With these 
considerations in mind, FDA seeks input on the following questions and 
welcomes any other relevant information the public would like to share.
     What types of user fees (e.g. product listing fees, 
facility fees, application fees, other types of fees) might be 
appropriate for a potential monograph user-fee program? Consider the 
following in your answer:
    [cir] For monograph products (unlike for products currently covered 
by user-fee programs), premarket applications are not generally 
submitted, and thus the approach regarding application-based fees might 
be expected to be different for a monograph user fee program compared 
to other user fee programs.
    [cir] Desirable industry activities or behavior that might be 
discouraged by the assessment of fees.
    [cir] The stability and predictability of the funding provided by 
the user-fee type.
     In conjunction with receiving user fees, FDA typically 
commits to certain performance goals related to the Agency's activities 
with respect to the relevant products. What types of performance goals 
might be important to consider from a public health and sponsor 
perspective? What parameters could be measured to gauge the success of 
a user-fee program?

III. Meeting Attendance and Participation

    The public meeting is free and seating will be on a first-come, 
first-served basis. FDA is seeking participation (i.e., attendance and 
oral presentations) at the public meeting by all interested parties. In 
general the meeting format may include, but will not be limited to, 
presentations by FDA staff, scientific and academic experts, health 
care professionals, representatives of patient and consumer advocacy 
groups, and representatives of the OTC monograph industry. If you wish 
to attend the public meeting either in person or by viewing the web 
cast, FDA asks that you please register through Eventbrite by Tuesday, 
May 31, 2016, in order for FDA to estimate the number of attendees 
(https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-public-meeting-tickets-21565448838).
    If you wish to make an oral presentation at the public meeting, you 
must register through Eventbrite by Tuesday, May 31, 2016 (https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-public-meeting-tickets-21565448838). FDA encourages individuals and 
organizations with common interests to coordinate and give a joint, 
consolidated presentation. FDA will try to accommodate all persons who 
wish to make a presentation; however, FDA may limit both the number of 
participants from individual organizations and the total number of 
attendees based on space and time limitations. FDA will notify 
registered presenters of their scheduled presentation times. Persons 
registered to speak should check in before the meeting and are 
encouraged to arrive early to ensure their designated order of 
presentation. Participants who are not present when called may not be 
permitted to speak at a later time. FDA will post an agenda of the 
public meeting and other background material at least 3 days before the 
public meeting and additional information will be available at: http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm.
    This public meeting will be web cast and the URL will be posted at 
http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm at least 1 day before 
the meeting. A video record of the public meeting will be available at 
the same Web site address for 1 year. If you need special 
accommodations because of disability, please contact Amy Bertha (see 
FOR FURTHER INFORMATION CONTACT) no later than Friday, May 27, 2016.

IV. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at http://www.regulations.gov. It may be viewed at 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A 
transcript will also be available in either hardcopy or on CD-ROM after 
submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov.

    Dated: May 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11098 Filed 5-10-16; 8:45 am]
 BILLING CODE 4164-01-P


