80 FR 63227 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 201 (October 19, 2015)

Page Range		63227-63227
FR Document		2015-26435

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 80 Issue 201 (Monday, October 19, 2015)

[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Page 63227]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-26435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; User Fee Cover Sheet;
Form FDA 3397

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 18, 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 0910-0297.
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.

User Fee Cover Sheet; Form FDA 3397 (OMB Control Number 0910-0297)--
Extension

Under the prescription drug user fee provisions of the Federal
Food, Drug, and Cosmetic Act (sections 735 and 736 (21 U.S.C. 379g and
379h)), as amended, FDA has the authority to assess and collect user
fees for certain drug and biologics license applications (BLAs) and
supplements to those applications. Under this authority, pharmaceutical
companies pay a fee for certain new human drug applications (NDAs),
BLAs, or supplements submitted to the Agency for review. Because the
submission of user fees concurrently with applications and supplements
is required, review of an application by FDA cannot begin until the fee
is submitted. The Prescription Drug User Fee Cover Sheet, Form FDA
3397, is designed to provide the minimum necessary information to
determine whether a fee is required for review of an application, to
determine the amount of the fee required, and to account for and track
user fees. The form provides a cross-reference of the fee submitted for
an application by using a unique number tracking system. The
information collected is used by FDA's Center for Drug Evaluation and
Research (CDER) and Center for Biologics Evaluation and Research (CBER)
to initiate the administrative screening of NDAs, BLAs, and/or,
supplemental applications to those applications.
Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2014, there are an estimated 290 manufacturers of products subject
to the Prescription Drug User Fee Act (Pub. L. 105-115). The total
number of annual responses is based on the number of submissions
received by FDA in FY 2014. CDER received 3,005 annual responses that
include the following submissions: 128 NDAs; 7 BLAs; 1,586
manufacturing supplements; 1,081 labeling supplements; and 203 efficacy
supplements. CBER received 705 annual responses that include the
following submissions: 11 BLAs; 611 manufacturing supplements; 64
labeling supplements; and 19 efficacy supplements. The estimated hours
per response are based on past FDA experience with the various
submissions.
In the Federal Register of April 15, 2015 (80 FR 20232), 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 Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3397........................................................... 290 12.79 3,710 0.5 (30 min.) 1,855
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26435 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices 63227

Dated: October 13, 2015. include the FDA docket number found form provides a cross-reference of the
Leslie Kux, in brackets in the heading of this fee submitted for an application by
Associate Commissioner for Policy. document. using a unique number tracking system.
[FR Doc. 2015–26439 Filed 10–16–15; 8:45 am] The information collected is used by
FOR FURTHER INFORMATION CONTACT: FDA
FDA’s Center for Drug Evaluation and
BILLING CODE 4164–01–P PRA Staff, Office of Operations, Food
Research (CDER) and Center for
and Drug Administration, 8455
Biologics Evaluation and Research
Colesville Rd., COLE–14526, Silver
DEPARTMENT OF HEALTH AND (CBER) to initiate the administrative
Spring, MD 20993–0002, PRAStaff@
HUMAN SERVICES screening of NDAs, BLAs, and/or,
fda.hhs.gov.
supplemental applications to those
Food and Drug Administration SUPPLEMENTARY INFORMATION: In applications.
[Docket No. FDA–2012–N–0471] compliance with 44 U.S.C. 3507, FDA Respondents to this collection of
has submitted the following proposed information are new drug and biologics
Agency Information Collection collection of information to OMB for manufacturers. Based on FDA’s database
Activities; Submission for Office of review and clearance. system for fiscal year (FY) 2014, there
Management and Budget Review; are an estimated 290 manufacturers of
User Fee Cover Sheet; Form FDA 3397
Comment Request; User Fee Cover products subject to the Prescription
(OMB Control Number 0910–0297)—
Sheet; Form FDA 3397 Drug User Fee Act (Pub. L. 105–115).
Extension
The total number of annual responses is
AGENCY: Food and Drug Administration, Under the prescription drug user fee based on the number of submissions
HHS. provisions of the Federal Food, Drug, received by FDA in FY 2014. CDER
ACTION: Notice. and Cosmetic Act (sections 735 and 736 received 3,005 annual responses that
(21 U.S.C. 379g and 379h)), as amended, include the following submissions: 128
SUMMARY: The Food and Drug FDA has the authority to assess and NDAs; 7 BLAs; 1,586 manufacturing
Administration (FDA) is announcing collect user fees for certain drug and supplements; 1,081 labeling
that a proposed collection of biologics license applications (BLAs) supplements; and 203 efficacy
information has been submitted to the and supplements to those applications. supplements. CBER received 705 annual
Office of Management and Budget Under this authority, pharmaceutical responses that include the following
(OMB) for review and clearance under companies pay a fee for certain new submissions: 11 BLAs; 611
the Paperwork Reduction Act of 1995. human drug applications (NDAs), BLAs, manufacturing supplements; 64 labeling
DATES: Fax written comments on the or supplements submitted to the Agency supplements; and 19 efficacy
collection of information by November for review. Because the submission of supplements. The estimated hours per
18, 2015. user fees concurrently with applications response are based on past FDA
ADDRESSES: To ensure that comments on and supplements is required, review of experience with the various
the information collection are received, an application by FDA cannot begin submissions.
OMB recommends that written until the fee is submitted. The In the Federal Register of April 15,
comments be faxed to the Office of Prescription Drug User Fee Cover Sheet, 2015 (80 FR 20232), FDA published a
Information and Regulatory Affairs, Form FDA 3397, is designed to provide 60-day notice requesting public
OMB, Attn: FDA Desk Officer, FAX: the minimum necessary information to comment on the proposed collection of
202–395–7285, or emailed to oira_ determine whether a fee is required for information. No comments were
submission@omb.eop.gov. All review of an application, to determine received.
comments should be identified with the the amount of the fee required, and to FDA estimates the burden of this
OMB control number 0910–0297. Also account for and track user fees. The collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA Form responses per burden per Total hours
respondents responses
respondent response

FDA 3397 ............................................................................. 290 12.79 3,710 0.5 (30 min.) 1,855
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 13, 2015. DEPARTMENT OF HEALTH AND ACTION: Notice.
Leslie Kux, HUMAN SERVICES
Associate Commissioner for Policy. SUMMARY: The Food and Drug
[FR Doc. 2015–26435 Filed 10–16–15; 8:45 am]
Food and Drug Administration Administration (FDA) is announcing
BILLING CODE 4164–01–P
that a collection of information entitled
[Docket No. FDA–2011–N–0776] ‘‘Reclassification Petitions for Medical
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Devices’’ has been approved by the
Agency Information Collection Office of Management and Budget
Activities; Announcement of Office of (OMB) under the Paperwork Reduction
Management and Budget Approval; Act of 1995.
Reclassification Petitions for Medical
Devices FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
AGENCY: Food and Drug Administration, and Drug Administration, 8455
HHS. Colesville Rd., COLE–14526, Silver

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Document Created: 2015-12-15 08:36:15
Document Modified: 2015-12-15 08:36:15

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 18, 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 63227

80 FR 63227 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 201 (October 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration