82_FR_43420 82 FR 43243 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)

82 FR 43243 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 177 (September 14, 2017)

Page Range43243-43244
FR Document2017-19492

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 82 Issue 177 (Thursday, September 14, 2017) 
[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43243-43244]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0594]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Focus Groups as Used 
by the Food and Drug Administration (All Food and Drug Administration-
Regulated Products)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
16, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0497. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance. Focus Groups as Used by the Food and Drug 
Administration (All FDA-Regulated Products), OMB Control Number 0910-
0497.
    FDA conducts voluntary focus group interviews on a variety of 
topics involving FDA-regulated products, including drugs, biologics, 
devices, food, tobacco, and veterinary medicine.
    Focus groups provide an important role in gathering information 
because they allow for a more in-depth understanding of patients' and 
consumers' attitudes, beliefs, motivations, and feelings than do 
quantitative studies. Focus groups serve the narrowly defined need for 
direct and informal opinion on a specific topic and as a qualitative 
research tool have three major purposes:
     To obtain patient and consumer information that is useful 
for developing variables and measures for quantitative studies,
     To better understand patients' and consumers' attitudes 
and emotions in response to topics and concepts, and
     To further explore findings obtained from quantitative 
studies.
    FDA will use focus group findings to test and refine their ideas, 
but will generally conduct further research before making important 
decisions such as adopting new policies and allocating or redirecting 
significant resources to support these policies.
    In the Federal Register of April 21, 2017 (82 FR 18763), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 43244]]

information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                              Activity                                  Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews.............................................           8,800                1            8,800             1.75           15,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19492 Filed 9-13-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43243 submission by the sponsor of an IND If paying by wire transfer, please DATES: Fax written comments on the describing an investigation that FDA reference your unique user fee ID collection of information by October 16, determines is intended to support a number when completing the transfer. 2017. biosimilar biological product The originating financial institution ADDRESSES: To ensure that comments on application. may charge a wire transfer fee. Please the information collection are received, The application fee for a biosimilar ask your financial institution about the OMB recommends that written biological product is due upon fee and include it with your payment to comments be faxed to the Office of submission of the application (see ensure that your fee is fully paid. The Information and Regulatory Affairs, section 744H(a)(2)(C) of the FD&C Act). account information for wire transfers is OMB, Attn: FDA Desk Officer, Fax: 202– To make a payment of the initial BPD, as follows: U.S. Department of Treasury, 395–7285, or emailed to oira_ reactivation, or application fee, TREAS NYC, 33 Liberty St., New York, submission@omb.eop.gov. All complete the Biosimilar User Fee Cover NY 10045, Acct. No.: 75060099, Routing comments should be identified with the Sheet, available on FDA’s Web site No.: 021030004, SWIFT: FRNYUS33, OMB control number 0910–0497. Also (http://www.fda.gov/bsufa) and generate Beneficiary: FDA, 8455 Colesville Rd., include the FDA docket number found a user fee identification (ID) number. 14th Floor, Silver Spring, MD 20993– in brackets in the heading of this Payment must be made in U.S. currency 0002. If needed, FDA’s tax identification document. by electronic check, check, bank draft, number is 53–0196965. U.S. postal money order, or wire FOR FURTHER INFORMATION CONTACT: transfer. The preferred payment method B. Annual BPD and Program Fees Amber Sanford, Office of Operations, is online using electronic check Food and Drug Administration, Three FDA will issue invoices for annual (Automated Clearing House (ACH) also White Flint North 10A–12M, 11601 BPD and program fees for FY 2018 known as eCheck) or credit card Landsdown St., North Bethesda, MD under the new fee schedule in (Discover, VISA, MasterCard, American 20852, 301–796–8867, PRAStaff@ September 2017. Payment instructions Express). Secure electronic payments fda.hhs.gov. will be included in the invoices, can be submitted using the User Fees including payment due dates. If SUPPLEMENTARY INFORMATION: In Payment Portal at https:// sponsors join the BPD program after the compliance with 44 U.S.C. 3507, FDA userfees.fda.gov/pay (Note: Only full annual BPD invoices have been issued has submitted the following proposed payments are accepted. No partial in September 2017, FDA will issue collection of information to OMB for payments can be made online). Once invoices in December 2017 to firms review and clearance. Focus Groups as you search for your invoice, click ‘‘Pay subject to fees for FY 2018 that qualify Used by the Food and Drug Now’’ to be redirected to Pay.gov. for the annual BPD fee after the Administration (All FDA-Regulated Electronic payment options are based on September 2017 billing. FDA will issue Products), OMB Control Number 0910– the balance due. Payment by credit card invoices in December 2017 for any 0497. is available for balances that are less annual program fees for FY 2018 that FDA conducts voluntary focus group than $25,000. If the balance exceeds this qualify for fee assessments and were not interviews on a variety of topics amount, only the ACH option is issued in September 2017. involving FDA-regulated products, available. Payments must be made using including drugs, biologics, devices, U.S. bank accounts as well as U.S. credit Dated: September 8, 2017. food, tobacco, and veterinary medicine. cards. Leslie Kux, Focus groups provide an important FDA has partnered with the U.S. Associate Commissioner for Policy. role in gathering information because Department of the Treasury to use [FR Doc. 2017–19493 Filed 9–13–17; 8:45 am] they allow for a more in-depth http://www.pay.gov, a web-based BILLING CODE 4164–01–P understanding of patients’ and payment application, for online consumers’ attitudes, beliefs, electronic payment. The Pay.gov feature motivations, and feelings than do is available on FDA’s Web site after DEPARTMENT OF HEALTH AND quantitative studies. Focus groups serve completing the Biosimilar User Fee HUMAN SERVICES the narrowly defined need for direct and Cover Sheet and generating the user fee informal opinion on a specific topic and ID number. Food and Drug Administration as a qualitative research tool have three Please include the user fee ID number major purposes: on your check, bank draft, or postal [Docket No. FDA–2010–N–0594] • To obtain patient and consumer money order, and make it payable to the information that is useful for developing Agency Information Collection Food and Drug Administration. Your variables and measures for quantitative Activities; Submission for Office of payment can be mailed to: Food and studies, Management and Budget Review; Drug Administration, P.O. Box 979108, • To better understand patients’ and Comment Request; Focus Groups as St. Louis, MO 63197–9000. To send a consumers’ attitudes and emotions in Used by the Food and Drug check by a courier such as Federal response to topics and concepts, and Administration (All Food and Drug Express or United Parcel Service, the Administration-Regulated Products) • To further explore findings courier must deliver the check and obtained from quantitative studies. printed copy of the cover sheet to: U.S. AGENCY: Food and Drug Administration, FDA will use focus group findings to Bank, ATTN: Government Lockbox HHS. test and refine their ideas, but will asabaliauskas on DSKBBXCHB2PROD with NOTICES 979108, 1005 Convention Plaza, St. ACTION: Notice. generally conduct further research Louis, MO 63101. (Note: This U.S. Bank before making important decisions such address is for courier delivery only. SUMMARY: The Food and Drug as adopting new policies and allocating Contact U.S. Bank at 314–418–4013 if Administration (FDA) is announcing or redirecting significant resources to you have any questions concerning that a proposed collection of support these policies. courier delivery.) Please make sure that information has been submitted to the In the Federal Register of April 21, the FDA post office box number (P.O. Office of Management and Budget 2017 (82 FR 18763), FDA published a Box 979108) is written on the check, (OMB) for review and clearance under 60-day notice requesting public bank draft, or postal money order. the Paperwork Reduction Act of 1995. comment on the proposed collection of VerDate Sep<11>2014 16:41 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1

43244 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices information. No comments were FDA estimates the burden of this received. collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Annual Number of Total annual Hours per Activity frequency Total hours respondents responses response per response Focus Group Interviews ....................................................... 8,800 1 8,800 1.75 15,400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 8, 2017. establish two different kinds of user drug program fee ($304,162). These fees Leslie Kux, fees. Fees are assessed on the following: are effective on October 1, 2017, and Associate Commissioner for Policy. (1) Application fees are assessed on will remain in effect through September [FR Doc. 2017–19492 Filed 9–13–17; 8:45 am] certain types of applications for the 30, 2018. For applications that are BILLING CODE 4164–01–P review of human drug and biological submitted on or after October 1, 2017, products; and (2) prescription drug the new fee schedule must be used. program fees are assessed on certain II. Fee Revenue Amount for FY 2018 DEPARTMENT OF HEALTH AND approved products (section 736(a) of the HUMAN SERVICES FD&C Act). When specific conditions The base revenue amount for FY 2018 are met, FDA may waive or reduce fees is $878,590,000 prior to adjustments for Food and Drug Administration (section 736(d) of the FD&C Act). inflation, capacity planning, additional [Docket No. FDA–2017–N–0007] For FY 2018 through FY 2022, the FTE, operating reserve, and additional base revenue amounts for the total direct costs (see section 736(b)(1) of the Prescription Drug User Fee Rates for revenues from all PDUFA fees are FD&C Act). Fiscal Year 2018 established by PDUFA VI. The base revenue amount for FY 2018 is A. FY 2018 Statutory Fee Revenue AGENCY: Food and Drug Administration, Adjustments for Inflation $878,590,000. The FY 2018 base HHS. revenue amount is to be adjusted for PDUFA VI specifies that the ACTION: Notice. inflation and for the resource capacity $878,590,000 is to be adjusted for SUMMARY: The Food and Drug needs for the process for the review of inflation increases for FY 2018 using Administration (FDA) is announcing the human drug applications (the capacity two separate adjustments—one for rates for prescription drug user fees for planning adjustment). An additional personnel compensation and benefits fiscal year (FY) 2018. The Federal Food, dollar amount specified in the statute (PC&B) and one for non-PC&B costs (see Drug, and Cosmetic Act (the FD&C Act), (see section 736(b)(1)(F) of the FD&C section 736(c)(1) of the FD&C Act). as amended by the Prescription Drug Act) is then added to provide for User Fee Amendments of 2017 (PDUFA additional full-time equivalent (FTE) The component of the inflation VI), authorizes FDA to collect positions to support PDUFA VI adjustment for payroll costs shall be one application fees for certain applications initiatives. The FY 2018 revenue plus the average annual percent change for the review of human drug and amount may be adjusted further, if in the cost of all PC&B paid per FTE biological products, and prescription necessary, to provide for sufficient positions at FDA for the first three of the drug program fees for certain approved operating reserves of carryover user fees. preceding four FYs, multiplied by the products. This notice establishes the fee Finally, the amount is adjusted to proportion of PC&B costs to total FDA rates for FY 2018. provide for additional direct costs to costs of the process for the review of FOR FURTHER INFORMATION CONTACT: fund PDUFA VI initiatives. Fee amounts human drug applications for the first Robert J. Marcarelli, Office of Financial are to be established each year so that three of the preceding four FYs (see Management, Food and Drug revenues from application fees provide section 736(c)(1)(A) and (c)(1)(B) of the Administration, 8455 Colesville Rd., 20 percent of the total revenue, and FD&C Act). COLE–14202F, Silver Spring, MD prescription drug program fees provide Table 1 summarizes the actual cost 20993–0002, 301–796–7223. 80 percent of the total revenue. and FTE data for the specified FYs and SUPPLEMENTARY INFORMATION: This document provides fee rates for provides the percent changes from the FY 2018 for an application requiring previous FYs and the average percent I. Background clinical data ($2,421,495), for an changes over the first three of the four Sections 735 and 736 of the FD&C Act application not requiring clinical data FYs preceding FY 2018. The 3-year (21 U.S.C. 379g and 379h, respectively) ($1,210,748), and for the prescription average is 2.2354 percent. TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES asabaliauskas on DSKBBXCHB2PROD with NOTICES 3-year Fiscal year 2014 2015 2016 average 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 VerDate Sep<11>2014 16:41 Sep 13, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\14SEN1.SGM 14SEN1


Document Created: 2017-09-13 23:49:36
Document Modified: 2017-09-13 23:49:36
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by October 16, 2017.
ContactAmber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation82 FR 43243 
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