82 FR 35965 - Over-the-Counter Monograph User Fees: Stakeholder Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 147 (August 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 147 (August 2, 2017)
| Page Range | 35965-35966 | |
| FR Document | 2017-16229 |
[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)] [Notices] [Pages 35965-35966] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16229] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Over-the-Counter Monograph User Fees: Stakeholder Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) will hold a webinar for stakeholders on August 23, 2017, to provide stakeholders with a status update on the process of FDA and industry discussions on an Over-the- Counter (OTC) Monograph user fee program that began in July 2016. FDA will also provide an overview of proposed performance goals and procedures related to a potential new OTC monograph user fee program. This webinar is intended to be a followup to the June 10, 2016, public meeting and the September 6, 2016, stakeholder webinar on a potential new OTC monograph user fee program. DATES: FDA will hold a webinar for stakeholders on Wednesday, August 23, 2017, from 12:30 p.m. to 2 p.m. EDT. FOR FURTHER INFORMATION CONTACT: Mary Vienna, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 301-796-4150, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Introduction On June 10, 2016, FDA held a public meeting on a potential new user fee program for nonprescription (over-the-counter or OTC) monograph drugs. In the announcement of the public meeting in the Federal Register (May 11, 2016, 81 FR 29275), FDA invited public comment as the Agency considers a user-fee program for 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. Interested persons were given until July 11, 2016, to submit comments. A stakeholder webinar was held on September 6, 2016, which provided stakeholders with a status update on the process of FDA and industry discussions that began in July 2016. In the notice of public meeting (August 8, 2016, 81 FR 52444), FDA invited public comments and interested parties were given until October 6, 2016, to submit comments. FDA will hold a webinar for stakeholders on August 23, 2017, to provide stakeholders with a status update on the process of FDA and industry discussions on an OTC Monograph user fee program that began in July 2016. FDA will also provide an overview of proposed performance goals and procedures related to a potential new OTC monograph user fee program. This webinar is intended to be a followup to the June 10, 2016, public meeting and the September 6, 2016, stakeholder webinar on a potential new OTC monograph user fee program. II. Background Meeting minutes from FDA and industry discussions on a new OTC monograph user fee program can be found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm. The proposed OTC Monograph User Fee Program Performance Goals and Procedures--Fiscal Years 2018-2022 document can also be found at that same Web site. Additional background information on OTC monograph drugs (such as how OTC drugs can be marketed, and the differences between marketing through approved applications and marketing under the monographs), factors FDA considers important in developing a user-fee program, and the questions for which FDA asked the public to consider and provide input, can be found in the Federal Register notice from the June 10, 2016, public meeting (https://www.federalregister.gov/articles/2016/05/11/2016-11098/over-the-counter-monograph-user-fees-public-meeting-request-for-comments). The meeting transcript, meeting recording, and presentations from the June 10, 2016, public meeting, which can serve as further background information, can be found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm. A summary of the September 6, 2016, stakeholders' webinar, can also be found at: https://www.fda.gov/ForIndustry/UserFees/OTCMonographUserFee/default.htm. III. Stakeholder Meeting Participation FDA is seeking participation at the webinar by stakeholders, including scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and representatives of the OTC monograph industry. Participating in the webinar is free. The webinar format [[Page 35966]] will include presentations by FDA staff and an opportunity for stakeholders to ask questions. If you wish to attend the webinar, FDA asks that you please register through Eventbrite by 12 a.m. EDT, Saturday, August 19, 2017: https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-stakeholder-meeting-registration-33593404778. FDA will email the registered attendees a URL to join the webinar at least 1 day before the meeting. Dated July 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16229 Filed 8-1-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices 35965
C. Fee Payment Procedures DEPARTMENT OF HEALTH AND invited public comments and interested
HUMAN SERVICES parties were given until October 6, 2016,
1. The preferred payment method is
to submit comments.
online using electronic check Food and Drug Administration FDA will hold a webinar for
(Automated Clearing House (ACH) also stakeholders on August 23, 2017, to
known as eCheck) or credit card Over-the-Counter Monograph User provide stakeholders with a status
(Discover, VISA, MasterCard, American Fees: Stakeholder Meeting update on the process of FDA and
Express). Secure electronic payments industry discussions on an OTC
can be submitted using the User Fees AGENCY: Food and Drug Administration,
HHS. Monograph user fee program that began
Payment Portal at https:// in July 2016. FDA will also provide an
userfees.fda.gov/pay. (Note: Only full ACTION: Notice of public meeting.
overview of proposed performance goals
payments are accepted. No partial and procedures related to a potential
SUMMARY: The Food and Drug
payments can be made online.) Once new OTC monograph user fee program.
Administration (FDA) will hold a
you search for your invoice, click ‘‘Pay webinar for stakeholders on August 23, This webinar is intended to be a
Now’’ to be redirected to Pay.gov. 2017, to provide stakeholders with a followup to the June 10, 2016, public
Electronic payment options are based on status update on the process of FDA and meeting and the September 6, 2016,
the balance due. Payment by credit card industry discussions on an Over-the- stakeholder webinar on a potential new
is available for balances less than Counter (OTC) Monograph user fee OTC monograph user fee program.
$25,000. If the balance exceeds this program that began in July 2016. FDA
amount, only the ACH option is II. Background
will also provide an overview of
available. Payments must be made using proposed performance goals and Meeting minutes from FDA and
U.S bank accounts as well as U.S. credit procedures related to a potential new industry discussions on a new OTC
cards. OTC monograph user fee program. This monograph user fee program can be
2. If paying with a paper check: webinar is intended to be a followup to found at: https://www.fda.gov/
Checks must be in U.S. currency from the June 10, 2016, public meeting and ForIndustry/UserFees/
a U.S. bank and made payable to the the September 6, 2016, stakeholder OTCMonographUserFee/default.htm.
Food and Drug Administration. webinar on a potential new OTC The proposed OTC Monograph User Fee
Payments can be mailed to: Food and monograph user fee program. Program Performance Goals and
Drug Administration, P.O. Box 979033, Procedures—Fiscal Years 2018–2022
DATES: FDA will hold a webinar for
St. Louis, MO 63197–9000. If a check is document can also be found at that
stakeholders on Wednesday, August 23,
sent by a courier that requests a street same Web site.
2017, from 12:30 p.m. to 2 p.m. EDT. Additional background information
address, the courier can deliver the
FOR FURTHER INFORMATION CONTACT: on OTC monograph drugs (such as how
check to: U.S. Bank, Attn: Government
Lockbox 979033, 1005 Convention Mary Vienna, Office of Executive OTC drugs can be marketed, and the
Plaza, St. Louis, MO 63101. (Note: This Programs, Center for Drug Evaluation differences between marketing through
U.S. Bank address is for courier delivery and Research, Food and Drug approved applications and marketing
only. If you have any questions Administration, 10903 New Hampshire under the monographs), factors FDA
concerning courier delivery, contact the Ave., Silver Spring, MD 20903–0002, considers important in developing a
U.S. Bank at 314–418–4013). 301–796–4150, email: user-fee program, and the questions for
3. When paying by wire transfer, the OTCMonographUserFeeProgram@ which FDA asked the public to consider
invoice number must be included. fda.hhs.gov. and provide input, can be found in the
Without the invoice number the SUPPLEMENTARY INFORMATION: Federal Register notice from the June
payment may not be applied. Regarding 10, 2016, public meeting (https://
I. Introduction
re-inspection fees, if the payment www.federalregister.gov/articles/2016/
amount is not applied, the invoice On June 10, 2016, FDA held a public 05/11/2016-11098/over-the-counter-
amount will be referred to collections. meeting on a potential new user fee monograph-user-fees-public-meeting-
The originating financial institution program for nonprescription (over-the- request-for-comments). The meeting
may charge a wire transfer fee. If the counter or OTC) monograph drugs. In transcript, meeting recording, and
financial institution charges a wire the announcement of the public meeting presentations from the June 10, 2016,
transfer fee, it is required that the in the Federal Register (May 11, 2016, public meeting, which can serve as
outsourcing facility add that amount to 81 FR 29275), FDA invited public further background information, can be
the payment to ensure that the invoice comment as the Agency considers a found at: https://www.fda.gov/
is paid in full. Use the following user-fee program for OTC monograph ForIndustry/UserFees/
account information when sending a drugs. A user-fee program would OTCMonographUserFee/default.htm. A
wire transfer: New York Federal Reserve provide funding to supplement summary of the September 6, 2016,
Bank, U.S. Dept of Treasury, TREAS congressional non-user-fee stakeholders’ webinar, can also be found
NYC, 33 Liberty St., New York, NY appropriations, and would support at: https://www.fda.gov/ForIndustry/
10045, Acct. No. 75060099, Routing No. timely and efficient FDA review of the UserFees/OTCMonographUserFee/
021030004, SWIFT: FRNYUS33, efficacy and safety of ingredients default.htm.
Beneficiary: FDA, 8455 Colesville Rd., included in or proposed for inclusion in
a monograph. Interested persons were III. Stakeholder Meeting Participation
14th Floor, Silver Spring, MD 20993–
given until July 11, 2016, to submit FDA is seeking participation at the
sradovich on DSKBCFCHB2PROD with NOTICES
0002. If needed, FDA’s tax identification
number is 53–0196965. comments. A stakeholder webinar was webinar by stakeholders, including
held on September 6, 2016, which scientific and academic experts, health
Dated: July 25, 2017. provided stakeholders with a status care professionals, representatives of
Leslie Kux, update on the process of FDA and patient and consumer advocacy groups,
Associate Commissioner for Policy. industry discussions that began in July and representatives of the OTC
[FR Doc. 2017–16185 Filed 8–1–17; 8:45 am] 2016. In the notice of public meeting monograph industry. Participating in
BILLING CODE 4164–01–P (August 8, 2016, 81 FR 52444), FDA the webinar is free. The webinar format
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![35966 Federal Register / Vol. 82, No. 147 / Wednesday, August 2, 2017 / Notices
will include presentations by FDA staff Administration, 7500 Standish Pl., issue invoices for FY 2018 product,
and an opportunity for stakeholders to Rockville, MD 20855, 240–402–6888. establishment, and sponsor fees by
ask questions. If you wish to attend the For general questions, you may also December 31, 2017, and payment will
webinar, FDA asks that you please email the Center for Veterinary be due by January 31, 2018. The
register through Eventbrite by 12 a.m. Medicine (CVM) at: cvmadufa@ application fee rates are effective for
EDT, Saturday, August 19, 2017: https:// fda.hhs.gov. applications submitted on or after
www.eventbrite.com/e/over-the-counter- SUPPLEMENTARY INFORMATION: October 1, 2017, and will remain in
monograph-user-fees-stakeholder- effect through September 30, 2018.
meeting-registration-33593404778. FDA I. Background Applications will not be accepted for
will email the registered attendees a Section 740 of the FD&C Act (21 review until FDA has received full
URL to join the webinar at least 1 day U.S.C. 379j–12) establishes four payment of application fees and any
before the meeting. different types of user fees: (1) Fees for other animal drug user fees owed under
Dated July 27, 2017. certain types of animal drug the Animal Drug User Fee program
Anna K. Abram, applications and supplements; (2) (ADUFA program).
Deputy Commissioner for Policy, Planning, annual fees for certain animal drug
II. Revenue Amount for FY 2018
Legislation, and Analysis. products; (3) annual fees for certain
[FR Doc. 2017–16229 Filed 8–1–17; 8:45 am]
establishments where such products are A. Statutory Fee Revenue Amounts
made; and (4) annual fees for certain
BILLING CODE 4164–01–P
sponsors of animal drug applications ADUFA III, Title I of Public Law 113–
and/or investigational animal drug 14, specifies that the aggregate fee
submissions (21 U.S.C. 379j–12(a)). revenue amount for FY 2018 for all
DEPARTMENT OF HEALTH AND
When certain conditions are met, FDA animal drug user fee categories is
HUMAN SERVICES
will waive or reduce fees (21 U.S.C. $21,600,000 (21 U.S.C. 379j–
Food and Drug Administration 379j–12(d)). 12(b)(1)(B)).
For FY 2014 through FY 2018, the B. Inflation Adjustment to Fee Revenue
[Docket No. FDA–2017–N–0007] FD&C Act establishes aggregate yearly Amount
Animal Drug User Fee Rates and base revenue amounts for each fiscal
Payment Procedures for Fiscal Year year (21 U.S.C. 379j–12(b)(1)). Base The fee revenue amount established
revenue amounts established for years in ADUFA III for FY 2015 and
2018
after FY 2014 are subject to adjustment subsequent fiscal years are subject to an
AGENCY: Food and Drug Administration, for inflation and workload (21 U.S.C. inflation adjustment (21 U.S.C. 379j–
HHS. 379j–12(c)). Fees for applications, 12(c)(2)).
ACTION: Notice. establishments, products, and sponsors
are to be established each year by FDA The component of the inflation
SUMMARY: The Food and Drug so that the percentages of the total adjustment for payroll costs shall be one
Administration (FDA) is announcing the revenue that are derived from each type plus the average annual percent change
rates and payment procedures for fiscal of user fee will be as follows: Revenue in the cost of all personnel
year (FY) 2018 animal drug user fees. from application fees shall be 20 percent compensation and benefits (PC&B) paid
The Federal Food, Drug, and Cosmetic of total fee revenue; revenue from per full-time equivalent position (FTE)
Act (the FD&C Act), as amended by the product fees shall be 27 percent of total at FDA for the first three of the four
Animal Drug User Fee Amendments of fee revenue; revenue from establishment preceding fiscal years, multiplied by the
2013 (ADUFA III), authorizes FDA to fees shall be 26 percent of total fee proportion of PC&B costs to total FDA
collect user fees for certain animal drug revenue; and revenue from sponsor fees costs for the first three of the four
applications and supplements, for shall be 27 percent of total fee revenue preceding fiscal years (see 21 U.S.C.
certain animal drug products, for certain (21 U.S.C. 379j–12(b)(2)). 379j–12(c)(2)(A) and (B)). The data on
establishments where such products are For FY 2018, the animal drug user fee total PC&B paid and numbers of FTE
made, and for certain sponsors of such rates are: $238,100 for an animal drug paid, from which the average cost per
animal drug applications and/or application; $119,050 for a FTE can be derived, are published in
investigational animal drug supplemental animal drug application FDA’s Justification of Estimates for
submissions. This notice establishes the for which safety or effectiveness data are Appropriations Committees.
fee rates for FY 2018. required and for an animal drug Table 1 summarizes that actual cost
FOR FURTHER INFORMATION CONTACT: Visit application subject to the criteria set and FTE data for the specified fiscal
FDA’s Web site at http://www.fda.gov/ forth in section 512(d)(4) of the FD&C years, and provides the percent change
ForIndustry/UserFees/AnimalDrugUser Act (21 U.S.C. 360b(d)(4)); $6,175 for an from the previous fiscal year and the
FeeActADUFA/default.htm or contact annual product fee; $88,750 for an average percent change over the first of
Lisa Kable, Center for Veterinary annual establishment fee; and $75,150 the 4 fiscal years preceding FY 2018.
Medicine (HFV–10), Food and Drug for an annual sponsor fee. FDA will The 3-year average is 2.2354 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year 2014 2015 2016 3-Year average
sradovich on DSKBCFCHB2PROD with NOTICES
Total PC&B .............................................................................. $2,054,937,000 $2,232,304,000 $2,414,728,159 ..............................
Total FTE ................................................................................. 14,555 15,484 16,381 ..............................
PC&B per FTE ......................................................................... $141,184 $144,168 $147,408 ..............................
Percent Change from Previous Year ...................................... 2.3451% 2.1136% 2.2474% 2.2354%
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Document Created: 2017-08-02 07:09:29
Document Modified: 2017-08-02 07:09:29
| 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 of public meeting. | |
| Dates | FDA will hold a webinar for stakeholders on Wednesday, August 23, 2017, from 12:30 p.m. to 2 p.m. EDT. | |
| Contact | Mary Vienna, Office of Executive Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002, 301-796-4150, email: [email protected] | |
| FR Citation | 82 FR 35965 |
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