80 FR 60394 - Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Generic Drug User Fee Cover Sheet
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 193 (October 6, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 193 (October 6, 2015)
| Page Range | 60394-60395 | |
| FR Document | 2015-25360 |
[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)] [Notices] [Pages 60394-60395] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [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. [[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
![60394 Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices
FDA may, for good cause, extend this The regulations provide that FDA Internet from April 1, 2015, through
30-day period. Reconsideration of a publish a quarterly list of available June 30, 2015. There were no denial
denial or withdrawal of approval of a safety and effectiveness summaries of actions during this period. The list
PMA may be sought only by the PMA approvals and denials that were provides the manufacturer’s name, the
applicant; in these cases, the 30-day announced during that quarter. The product’s generic name or the trade
period will begin when the applicant is following is a list of approved PMAs for name, and the approval date.
notified by FDA in writing of its which summaries of safety and
decision. effectiveness were placed on the
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 Approval date
P140003, FDA–2015–M–1177 ABIOMED, Inc ........................ Impella® 2.5 System ................................................................ 3/23/2015
P130014, FDA–2015–M–1065 HyperBranch Medical Tech- Adherus® AutoSpray Dural Sealant ......................................... 3/30/2015
nology, Inc.
P130021/S010, FDA–2015–M– Medtronic CoreValve, LLC ..... Medtronic CoreValve® System ................................................ 3/30/2015
1064.
P110015, FDA–2015–M–1178 Advanced Breath Diagnostics, Gastric Emptying Breath Test (GEBT) .................................... 4/6/2015
LLC.
P040020/S050, FDA–2015–M– Alcon Research, Ltd ............... AcrySof IQ ReSTOR +2.5 D Multifocal Intraocular Lens ........ 4/13/2015
1325.
P120023, FDA–2015–M–1326 AcuFocusTM, Inc ..................... KAMRATM inlay ........................................................................ 4/17/2015
H130007, FDA–2014–M–2247 CVRx®, Inc ............................. Barostim neoTM Legacy System .............................................. 12/12/2014
P140011, FDA–2015–M–1460 Siemens Medical Solutions MAMMOMAT Inspiration with Tomosynthesis Option ............. 4/21/2015
USA, Inc.
P120017, FDA–2015–M–1461 Medtronic, Inc ......................... Model 5071 Lead ..................................................................... 4/27/2015
P130012, FDA–2015–M–1557 Greatbatch Medical ................. Myopore Sutureless Myocardial Pacing Lead ......................... 4/30/2015
P140023, FDA–2015–M–1708 Roche Molecular Systems, Inc cobas® KRAS Mutation Test ................................................... 5/7/2015
P130022, FDA–2015–M–1709 Nevro Corp ............................. Nevro Senza Spinal Cord Stimulation (SCS) System ............. 5/8/2015
P140026, FDA–2015–M–1956 Silk Road Medical, Inc ............ ENROUTETM Transcarotid Stent System ................................ 5/18/2015
P140004, FDA–2015–M–1957 Vertiflex®, Inc .......................... Superion® InterSpinous Spacer ............................................... 5/20/2015
P140002, FDA–2015–M–1958 Terumo Medical Corp ............. Misago® Peripheral Self-expanding Stent System .................. 5/22/2015
P120005/S031, FDA–2015–M– Dexcom, Inc ............................ Dexcom G4®PLATINUM (Pediatric) Continuous Glucose 5/22/2015
1959. Monitoring System.
P110010/S096, FDA–2015–M– Boston Scientific Corp ............ PROMUS® ElementTM Plus and Promus PREMIERTM 6/1/2015
2077. Everolimus-Eluting Platinum Chromium Coronary Stent
System (MonorailTM and Over-the-Wire).
P050052/S049, FDA–2015–M– Merz North America ................ Radiesse® Injectable Implant ................................................... 6/4/2015
2078.
II. Electronic Access DEPARTMENT OF HEALTH AND ADDRESSES: To ensure that comments on
HUMAN SERVICES the information collection are received,
Persons with access to the Internet OMB recommends that written
may obtain the documents at http:// Food and Drug Administration comments be faxed to the Office of
www.fda.gov/MedicalDevices/ Information and Regulatory Affairs,
ProductsandMedicalProcedures/ [Docket No. FDA–2012–N–0748] OMB, Attn: FDA Desk Officer, FAX:
DeviceApprovalsandClearances/ 202–395–7285, or emailed to oira_
PMAApprovals/default.htm. Agency Information Collection submission@omb.eop.gov. All
Dated: September 30, 2015. Activities; Proposed Collection; comments should be identified with the
Submission for Office of Management OMB control number 0910–0727. Also
Leslie Kux,
and Budget Review; Guidance for
Associate Commissioner for Policy. include the FDA docket number found
Industry on Generic Drug User Fee
[FR Doc. 2015–25352 Filed 10–5–15; 8:45 am] in brackets in the heading of this
Cover Sheet
document.
BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration,
HHS. FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
ACTION: Notice. and Drug Administration, 8455
SUMMARY: The Food and Drug Colesville Rd., COLE–14526, Silver
Administration (FDA) is announcing Spring, MD 20993–0002, PRAStaff@
that a proposed collection of fda.hhs.gov.
information has been submitted to the
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: In
Office of Management and Budget
compliance with 44 U.S.C. 3507, FDA
(OMB) for review and clearance under
has submitted the following proposed
the Paperwork Reduction Act of 1995.
collection of information to OMB for
DATES: Fax written comments on the review and clearance.
collection of information by November
5, 2015.
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![Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60395
Generic Drug User Fee Cover Sheet; to calculate and pay generic drug user application and facility. Based on FDA’s
Form FDA 3794 OMB Control Number fees. Proposed Form FDA 3794, the database of application holders and
0910–0727—Extension Generic Drug User Fee Cover Sheet, related manufacturers, we estimate that
On July 9, 2012, the Generic Drug requests the minimum necessary approximately 460 companies would
User Fee Act (GDUFA) (Pub. L. 112– information to determine if a person has submit a total of 3,544 cover sheets
144, Title III) was signed into law by the satisfied all relevant user fee annually to pay for application and
President. GDUFA, designed to speed obligations. The proposed form is facility user fees. FDA estimates that the
the delivery of safe and effective generic modeled on other FDA user fee cover 3,544 annual cover sheet responses
drugs to the public and reduce costs to sheets, including Form FDA 3397, the would break down as follows: 1,439
industry, requires that generic drug Prescription Drug User Fee Act Cover facilities fees, 942 ANDAs, 502 PASs,
manufacturers pay user fees to finance Sheet. The information collected would and 661 Type II API DMFs. The
critical and measurable program be used by FDA to initiate the estimated hours per response are based
enhancements. The user fees required administrative screening of generic drug on FDA’s past experience with other
by GDUFA are as follows: (1) A one- submissions and DMFs, support the submissions and range from
time fee for original abbreviated new inspection of generic drug facilities, and approximately 0.1 to 0.5 hours. The
drug applications (ANDAs) pending on otherwise support the generic drug hours per response are estimated at the
October 1, 2012 (also known as backlog program. A copy of the proposed form upper end of the range to be
applications); (2) fees for type II active will be available in the docket for this conservative.
pharmaceutical ingredient (API) and notice.
Respondents to this proposed In the Federal Register of June 2, 2015
final dosage form (FDF) facilities; (3)
collection of information would be (80 FR 31388), FDA published a 60-day
fees for new ANDAs and prior approval
supplements (PASs); and (4) a one-time potential or actual generic application notice requesting public comment on
fee for drug master files (DMFs). holders and/or related manufacturers the proposed collection of information.
The purpose of this notice is to solicit (manufacturers of FDF and/or APIs). No comments were received.
feedback on the collection of Companies with multiple applications FDA estimates the burden of this
information in an electronic form used will submit a cover sheet for each collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual
FDA Form responses per Average burden per response Total hours
respondents responses
respondent
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. Name of Committee: Arthritis and DEPARTMENT OF HEALTH AND
Leslie Kux, Musculoskeletal and Skin Diseases Initial HUMAN SERVICES
Associate Commissioner for Policy. Review Group; Arthritis and Musculoskeletal
[FR Doc. 2015–25360 Filed 10–5–15; 8:45 am] and Skin Diseases Clinical Trials Review National Institutes of Health
Committee: AMSC–1 Clinical Trials Review
BILLING CODE 4164–01–P
Meeting. National Institute of Neurological
Date: October 27–28, 2015. Disorders and Stroke; Notice of Closed
DEPARTMENT OF HEALTH AND Time: 8:00 a.m. to 5:00 p.m. Meetings
HUMAN SERVICES Agenda: To review and evaluate grant
applications. Pursuant to section 10(d) of the
National Institutes of Health Place: Bethesda Marriott Suites, 6711 Federal Advisory Committee Act, as
Democracy Boulevard, Bethesda, MD 20817. amended (5 U.S.C. App.), notice is
National Institute of Arthritis and Contact Person: Charles H. Washabaugh, hereby given of the following meetings.
Musculoskeletal and Skin Diseases; Ph.D., Scientific Review Officer, Scientific The meetings will be closed to the
Notice of Closed Meeting Review Branch, NIAMS/NIH, 6701 public in accordance with the
Democracy Boulevard, Suite 816, Bethesda, provisions set forth in sections
Pursuant to section 10(d) of the
MD 20892, 301–594–4952, washabac@
Federal Advisory Committee Act, as 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
mail.nih.gov.
amended (5 U.S.C. App.), notice is as amended. The grant applications and
hereby given of the following meeting. (Catalogue of Federal Domestic Assistance the discussions could disclose
The meeting will be closed to the Program Nos. 93.846, Arthritis, confidential trade secrets or commercial
public in accordance with the Musculoskeletal and Skin Diseases Research, property such as patentable material,
provisions set forth in sections National Institutes of Health, HHS) and personal information concerning
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Dated: September 30, 2015. individuals associated with the grant
as amended. The grant applications and applications, the disclosure of which
Carolyn Baum,
the discussions could disclose would constitute a clearly unwarranted
Program Analyst, Office of Federal Advisory
tkelley on DSK3SPTVN1PROD with NOTICES
confidential trade secrets or commercial invasion of personal privacy.
property such as patentable material, Committee Policy.
[FR Doc. 2015–25317 Filed 10–5–15; 8:45 am] Name of Committee: National Institute of
and personal information concerning Neurological Disorders and Stroke Special
individuals associated with the grant BILLING CODE 4140–01–P
Emphasis Panel; NINDS Research Resource
applications, the disclosure of which Opportunities Review.
would constitute a clearly unwarranted Date: November 2, 2015.
invasion of personal privacy. Time: 11:00 a.m. to 12:30 p.m.
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Document Created: 2015-12-15 08:51:08
Document Modified: 2015-12-15 08:51:08
| 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. | |
| Dates | Fax written comments on the collection of information by November 5, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 60394 |
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