Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet, 60394-60395 [2015-25360]

Download as PDF 60394 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from April 1, 2015, through June 30, 2015. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 2015 THROUGH JUNE 30, 2015 PMA No., Docket No. Applicant Trade name P140003, FDA–2015–M–1177 P130014, FDA–2015–M–1065 ABIOMED, Inc ........................ HyperBranch Medical Technology, Inc. Medtronic CoreValve, LLC ..... Impella® 2.5 System ................................................................ Adherus® AutoSpray Dural Sealant ......................................... 3/23/2015 3/30/2015 Medtronic CoreValve® System ................................................ 3/30/2015 Advanced Breath Diagnostics, LLC. Alcon Research, Ltd ............... Gastric Emptying Breath Test (GEBT) .................................... 4/6/2015 AcrySof IQ ReSTOR +2.5 D Multifocal Intraocular Lens ........ 4/13/2015 KAMRATM inlay ........................................................................ Barostim neoTM Legacy System .............................................. MAMMOMAT Inspiration with Tomosynthesis Option ............. 4/17/2015 12/12/2014 4/21/2015 Model 5071 Lead ..................................................................... Myopore Sutureless Myocardial Pacing Lead ......................... cobas® KRAS Mutation Test ................................................... Nevro Senza Spinal Cord Stimulation (SCS) System ............. ENROUTETM Transcarotid Stent System ................................ Superion® InterSpinous Spacer ............................................... Misago® Peripheral Self-expanding Stent System .................. Dexcom G4®PLATINUM (Pediatric) Continuous Glucose Monitoring System. PROMUS® ElementTM Plus and Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Over-the-Wire). Radiesse® Injectable Implant ................................................... 4/27/2015 4/30/2015 5/7/2015 5/8/2015 5/18/2015 5/20/2015 5/22/2015 5/22/2015 P130021/S010, FDA–2015–M– 1064. P110015, FDA–2015–M–1178 P040020/S050, FDA–2015–M– 1325. P120023, FDA–2015–M–1326 H130007, FDA–2014–M–2247 P140011, FDA–2015–M–1460 P120017, FDA–2015–M–1461 P130012, FDA–2015–M–1557 P140023, FDA–2015–M–1708 P130022, FDA–2015–M–1709 P140026, FDA–2015–M–1956 P140004, FDA–2015–M–1957 P140002, FDA–2015–M–1958 P120005/S031, FDA–2015–M– 1959. P110010/S096, FDA–2015–M– 2077. P050052/S049, FDA–2015–M– 2078. AcuFocusTM, Inc ..................... CVRx®, Inc ............................. Siemens Medical Solutions USA, Inc. Medtronic, Inc ......................... Greatbatch Medical ................. Roche Molecular Systems, Inc Nevro Corp ............................. Silk Road Medical, Inc ............ Vertiflex®, Inc .......................... Terumo Medical Corp ............. Dexcom, Inc ............................ Boston Scientific Corp ............ Merz North America ................ II. Electronic Access Persons with access to the Internet may obtain the documents at https:// www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ DeviceApprovalsandClearances/ PMAApprovals/default.htm. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25352 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0748] Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 November 5, 2015. tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Approval date 6/1/2015 6/4/2015 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0727. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\06OCN1.SGM 06OCN1 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices Generic Drug User Fee Cover Sheet; Form FDA 3794 OMB Control Number 0910–0727—Extension On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 112– 144, Title III) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug manufacturers pay user fees to finance critical and measurable program enhancements. The user fees required by GDUFA are as follows: (1) A onetime fee for original abbreviated new drug applications (ANDAs) pending on October 1, 2012 (also known as backlog applications); (2) fees for type II active pharmaceutical ingredient (API) and final dosage form (FDF) facilities; (3) fees for new ANDAs and prior approval supplements (PASs); and (4) a one-time fee for drug master files (DMFs). The purpose of this notice is to solicit feedback on the collection of information in an electronic form used to calculate and pay generic drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover Sheet, requests the minimum necessary information to determine if a person has satisfied all relevant user fee obligations. The proposed form is modeled on other FDA user fee cover sheets, including Form FDA 3397, the Prescription Drug User Fee Act Cover Sheet. The information collected would be used by FDA to initiate the administrative screening of generic drug submissions and DMFs, support the inspection of generic drug facilities, and otherwise support the generic drug program. A copy of the proposed form will be available in the docket for this notice. Respondents to this proposed collection of information would be potential or actual generic application holders and/or related manufacturers (manufacturers of FDF and/or APIs). Companies with multiple applications will submit a cover sheet for each 60395 application and facility. Based on FDA’s database of application holders and related manufacturers, we estimate that approximately 460 companies would submit a total of 3,544 cover sheets annually to pay for application and facility user fees. FDA estimates that the 3,544 annual cover sheet responses would break down as follows: 1,439 facilities fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated hours per response are based on FDA’s past experience with other submissions and range from approximately 0.1 to 0.5 hours. The hours per response are estimated at the upper end of the range to be conservative. In the Federal Register of June 2, 2015 (80 FR 31388), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 FDA Form Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 3794 .................................................. 460 7.7 3,544 0.5 (30 minutes) ............................... 1,772 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–25360 Filed 10–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health tkelley on DSK3SPTVN1PROD with NOTICES National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 Name of Committee: Arthritis and Musculoskeletal and Skin Diseases Initial Review Group; Arthritis and Musculoskeletal and Skin Diseases Clinical Trials Review Committee: AMSC–1 Clinical Trials Review Meeting. Date: October 27–28, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Charles H. Washabaugh, Ph.D., Scientific Review Officer, Scientific Review Branch, NIAMS/NIH, 6701 Democracy Boulevard, Suite 816, Bethesda, MD 20892, 301–594–4952, washabac@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research, National Institutes of Health, HHS) Dated: September 30, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–25317 Filed 10–5–15; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; NINDS Research Resource Opportunities Review. Date: November 2, 2015. Time: 11:00 a.m. to 12:30 p.m. E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60394-60395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25360]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0748]


Agency Information Collection Activities; Proposed Collection; 
Submission for Office of Management and Budget Review; Guidance for 
Industry on Generic Drug User Fee Cover Sheet

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 
November 5, 2015.

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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0727. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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.

[[Page 60395]]

Generic Drug User Fee Cover Sheet; Form FDA 3794 OMB Control Number 
0910-0727--Extension

    On July 9, 2012, the Generic Drug User Fee Act (GDUFA) (Pub. L. 
112-144, Title III) was signed into law by the President. GDUFA, 
designed to speed the delivery of safe and effective generic drugs to 
the public and reduce costs to industry, requires that generic drug 
manufacturers pay user fees to finance critical and measurable program 
enhancements. The user fees required by GDUFA are as follows: (1) A 
one-time fee for original abbreviated new drug applications (ANDAs) 
pending on October 1, 2012 (also known as backlog applications); (2) 
fees for type II active pharmaceutical ingredient (API) and final 
dosage form (FDF) facilities; (3) fees for new ANDAs and prior approval 
supplements (PASs); and (4) a one-time fee for drug master files 
(DMFs).
    The purpose of this notice is to solicit feedback on the collection 
of information in an electronic form used to calculate and pay generic 
drug user fees. Proposed Form FDA 3794, the Generic Drug User Fee Cover 
Sheet, requests the minimum necessary information to determine if a 
person has satisfied all relevant user fee obligations. The proposed 
form is modeled on other FDA user fee cover sheets, including Form FDA 
3397, the Prescription Drug User Fee Act Cover Sheet. The information 
collected would be used by FDA to initiate the administrative screening 
of generic drug submissions and DMFs, support the inspection of generic 
drug facilities, and otherwise support the generic drug program. A copy 
of the proposed form will be available in the docket for this notice.
    Respondents to this proposed collection of information would be 
potential or actual generic application holders and/or related 
manufacturers (manufacturers of FDF and/or APIs). Companies with 
multiple applications will submit a cover sheet for each application 
and facility. Based on FDA's database of application holders and 
related manufacturers, we estimate that approximately 460 companies 
would submit a total of 3,544 cover sheets annually to pay for 
application and facility user fees. FDA estimates that the 3,544 annual 
cover sheet responses would break down as follows: 1,439 facilities 
fees, 942 ANDAs, 502 PASs, and 661 Type II API DMFs. The estimated 
hours per response are based on FDA's past experience with other 
submissions and range from approximately 0.1 to 0.5 hours. The hours 
per response are estimated at the upper end of the range to be 
conservative.
    In the Federal Register of June 2, 2015 (80 FR 31388), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                    FDA Form                         Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
3794............................................             460              7.7            3,544   0.5 (30 minutes)..................           1,772
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: September 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25360 Filed 10-5-15; 8:45 am]
 BILLING CODE 4164-01-P
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