Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 15623 [2019-07467]
Download as PDF
<![CDATA[
15623
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Notices
and Form FDA 3538 to facilitate the
electronic submission of such
information. We use the information
collected with Form FDA 3538 to
register respondents to use the CVM
ESS.
Description of Respondents: The
respondents are sponsors of new animal
drug applications.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
FDA Form No.
11.2 ...................
Form FDA 3538 ................
1 There
Number of
responses per
respondent
179
Total annual
responses
1.3
Average burden
per response
233
Total hours
.08 (5 minutes) ..................
19
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our
experience with the submission of
electronic information using the CVM
ESS and the number of electronic
registration or change requests received
between January 1, 2018, and November
30, 2018. Our estimated burden for the
information collection reflects an
overall increase of 16 hours and a
corresponding increase of 195
responses. We attribute this adjustment
to the reauthorizations of both the
Animal Drug User Fee Act and the
Animal Generic Drug User Fee Act,
which require sponsors to submit
information electronically to the CVM’s
Office of New Animal Drug Evaluation.
Because of this requirement, sponsors
are now registering to use the CVM ESS
in greater numbers than in previous
years.
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–07468 Filed 4–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–N–0742; FDA–
2018–N–1967; FDA–2018–N–2970; FDA–
2017–N–1779; FDA–2008–N–0500; FDA–
2012–N–0129; FDA–2009–D–0268; FDA–
2014–D–0609; and FDA–2011–N–0776]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
SUMMARY:
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
khammond on DSKBBV9HB2PROD with NOTICES
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution ............................................
Biosimilar User Fee Program ..................................................................................................................................
Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices
with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act ..........................
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion ........................
Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products ..........
General Licensing Provisions; Section 351(k) Biosimilar Applications ...................................................................
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA ...........................................................
Implementation of the Drug Supply Chain Security Act—Identification of Suspect Product and Notification ........
Reclassification Petitions for Medical Devices ........................................................................................................
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–07467 Filed 4–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
16:32 Apr 15, 2019
Jkt 247001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0045
0910–0718
12/31/2021
12/31/2021
0910–0863
0910–0864
0910–0572
0910–0719
0910–0728
0910–0806
0910–0138
12/31/2021
12/31/2021
1/31/2022
1/31/2022
1/31/2022
1/31/2022
2/28/2022
amended, 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,
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Page 15623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07467]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-N-0742; FDA-2018-N-1967; FDA-2018-N-2970; FDA-
2017-N-1779; FDA-2008-N-0500; FDA-2012-N-0129; FDA-2009-D-0268; FDA-
2014-D-0609; and FDA-2011-N-0776]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Registration of Producers of Drugs and 0910-0045 12/31/2021
Listing of Drugs in Commercial
Distribution...........................
Biosimilar User Fee Program............. 0910-0718 12/31/2021
Surveys and Interviews with 0910-0863 12/31/2021
Investigational New Drug Sponsors to
Assess Current Communication Practices
with FDA Review Staff Under the Sixth
Authorization of the Prescription Drug
User Fee Act...........................
Disclosures of Descriptive Presentations 0910-0864 12/31/2021
in Professional Oncology Prescription
Drug Promotion.........................
Requirements on Content and Format of 0910-0572 1/31/2022
Labeling for Human Prescription Drug
and Biological Products................
General Licensing Provisions; Section 0910-0719 1/31/2022
351(k) Biosimilar Applications.........
Labeling of Certain Beers Subject to the 0910-0728 1/31/2022
Labeling Jurisdiction of the FDA.......
Implementation of the Drug Supply Chain 0910-0806 1/31/2022
Security Act--Identification of Suspect
Product and Notification...............
Reclassification Petitions for Medical 0910-0138 2/28/2022
Devices................................
------------------------------------------------------------------------
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-07467 Filed 4-15-19; 8:45 am]
BILLING CODE 4164-01-P
