Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, 78740-78741 [2015-31696]
Download as PDF
<![CDATA[
78740
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
assistance (no script), with a decrease of
106 burden hours.
These adjustments result in a decrease
of 55,994 burden hours.
CDC requested a total of 38,817
respondents and 29,388 burden hours
annually. The respondents to these
information collections are travelers and
ship medical personnel. There is no cost
to respondents other than the time
required to provide the information
requested.
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Traveler .............................................
Airline Travel Illness or Death Investigation Form.
Maritime Conveyance Illness or
Death Investigation Form.
Land Travel Illness or Death Investigation Form.
Ebola Risk Assessment Form (Ill
traveler
interview:
English,
French, Arabic, or other as needed).
United States Traveler Health Declaration (English: Hard Copy,
fillable PDF, electronic portal).
United States Traveler Health Declaration (French translation guide).
United States Traveler Health Declaration (Arabic translation guide).
Ebola Risk Assessment Form
(English hard copy).
Ebola Risk Assessment French
translation guide.
Ebola Risk Assessment Arabic
translation guide.
IVR Active Monitoring Survey
(English: Recorded).
IVR Active Monitoring Survey
(French: Recorded).
IVR Active Monitoring: Arabic translation assistance (no script).
Ship Medical Personnel ....................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Traveler .............................................
Total ...........................................
...........................................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–31742 Filed 12–16–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2011–D–0164]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Safety Labeling Changes—
Implementation of Section 505(o)(4) of
the Federal Food, Drug, and Cosmetic
Act
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:53 Dec 16, 2015
Jkt 238001
ACTION:
Number of
responses per
respondent
Number of
respondents
Respondent
1
5/60
150
750
1
5/60
63
100
1
5/60
8
100
1
15/60
25
9,000
1
15/60
2250
8,400
1
15/60
2100
100
1
15/60
25
810
1
15/60
203
252
1
15/60
63
5
1
15/60
1
9,000
21
4/60
12,600
8,400
21
4/60
11,760
100
21
4/60
140
38,817
........................
........................
29,388
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 January 19,
2016.
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 0910–0734. 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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Total burden
hours
1,800
Notice.
SUMMARY:
Average
burden per
response
(in minutes)
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.
Guidance for Industry on Safety
Labeling Changes—Implementation of
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act, OMB Control
Number 0910–0734—Extension
Section 505(o)(4) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 355(o)(4)) authorizes FDA to
require, and if necessary, order labeling
changes if FDA becomes aware of new
safety information that FDA believes
should be included in the labeling of
certain prescription drug and biological
products approved under section 505 of
the FD&C Act or section 351 of the PHS
Act (42 U.S.C. 262). Section 505(o)(4) of
the FD&C Act applies to prescription
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
drug products with an approved new
drug application (NDA) under section
505(b) of the FD&C Act, biological
products with an approved biologics
license application under section 351 of
the PHS Act, or prescription drug
products with an approved abbreviated
new drug application under section
505(j) of the FD&C Act if the reference
listed drug with an approved NDA is
not currently marketed. Section
505(o)(4) imposes timeframes for
application holders to submit and FDA
staff to review such changes, and gives
FDA new enforcement tools to bring
about timely and appropriate labeling
changes. The guidance provides
information on the implementation of
the new provisions, including a
description of the types of safety
labeling changes that ordinarily might
be required under the new legislation,
how FDA plans to determine what
constitutes new safety information, the
procedures involved in requiring safety
labeling changes, and enforcement of
the requirements for safety labeling
changes.
FDA requires safety labeling changes
by sending a notification letter to the
application holder. Under section
505(o)(4)(B), the application holder
must respond to FDA’s notification by
submitting a labeling supplement or
notifying FDA that the applicant does
not believe the labeling change is
warranted and submitting a statement
detailing the reasons why the
application holder does not believe a
change is warranted (a rebuttal
statement).
Based on FDA’s experience to date
with safety labeling changes
requirements under section 505(o)(4),
we estimate that approximately 42
application holders will elect to submit
approximately one rebuttal statement
78741
each year and that each rebuttal
statement will take approximately 6
hours to prepare.
In addition, in the guidance, FDA
states that new labeling prepared in
response to a safety labeling change
notification should be available on the
application holder’s Web site within 10
calendar days of approval. FDA
estimates that approximately 407
application holders will post new
labeling one time each year in response
to a safety labeling change notification
and that the posting of the labeling will
take approximately 4 hours to prepare.
In the Federal Register of September
2, 2015 (80 FR 53161), 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
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
42
1
42
6
252
Rebuttal statement ...............................................................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of submission
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Posting approved labeling on application holder’s Web site
407
1
407
4
1,628
1 There
are no capital costs or operating and maintenance costs associated with this collect of information.
Dated: December 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31696 Filed 12–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2010–D–0226]
Medical Device ISO 13485:2003
Voluntary Audit Report Pilot Program;
Termination of Pilot Program;
Announcement of the Medical Device
Single Audit Program Operational
Phase
AGENCY:
Food and Drug Administration,
DATES:
This notice is effective March 31,
2016.
FOR FURTHER INFORMATION CONTACT:
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
termination of the Medical Device ISO
Voluntary Audit Report Pilot Program.
This program allowed the submission of
ISO audit reports performed by third
parties, along with audit reports from
the preceding 2 years, to determine if
the owner or operator of the medical
device establishment could be removed
from FDA’s routine inspection work
plan for 1 year. FDA is also announcing
its participation in the operational
phase of the Medical Device Single
Audit Program (MDSAP), which will
allow third parties recognized by the
MDSAP consortium to submit audit
reports that FDA will utilize for routine
inspections.
SUMMARY:
Robert Ruff, Center for Devices and
Radiological Health, Food and Drug
Notice.
VerDate Sep<11>2014
18:13 Dec 16, 2015
Jkt 238001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3615, Silver Spring,
MD 20993–0002, 301–796–6556.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 19,
2012 (77 FR 16036), FDA announced the
availability of a final guidance entitled
‘‘Guidance for Industry, Third Parties
and Food and Drug Administration
Staff: Medical Device ISO 13485:2003
Voluntary Audit Report Submission
Pilot Program’’ (Ref. 1). This guidance
document was effective on June 5, 2012,
and as stated in the guidance was an
interim measure while developing a
single audit program, to implement
section 228 of the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), which amended
section 704(g)(7) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
374(g)(7)). The pilot allowed the owner
or operator of the medical device
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78740-78741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31696]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0164]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Safety Labeling Changes--Implementation of Section 505(o)(4) of the
Federal Food, Drug, and Cosmetic Act
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 January
19, 2016.
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 0910-0734.
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.
Guidance for Industry on Safety Labeling Changes--Implementation of
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, OMB
Control Number 0910-0734--Extension
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require, and if
necessary, order labeling changes if FDA becomes aware of new safety
information that FDA believes should be included in the labeling of
certain prescription drug and biological products approved under
section 505 of the FD&C Act or section 351 of the PHS Act (42 U.S.C.
262). Section 505(o)(4) of the FD&C Act applies to prescription
[[Page 78741]]
drug products with an approved new drug application (NDA) under section
505(b) of the FD&C Act, biological products with an approved biologics
license application under section 351 of the PHS Act, or prescription
drug products with an approved abbreviated new drug application under
section 505(j) of the FD&C Act if the reference listed drug with an
approved NDA is not currently marketed. Section 505(o)(4) imposes
timeframes for application holders to submit and FDA staff to review
such changes, and gives FDA new enforcement tools to bring about timely
and appropriate labeling changes. The guidance provides information on
the implementation of the new provisions, including a description of
the types of safety labeling changes that ordinarily might be required
under the new legislation, how FDA plans to determine what constitutes
new safety information, the procedures involved in requiring safety
labeling changes, and enforcement of the requirements for safety
labeling changes.
FDA requires safety labeling changes by sending a notification
letter to the application holder. Under section 505(o)(4)(B), the
application holder must respond to FDA's notification by submitting a
labeling supplement or notifying FDA that the applicant does not
believe the labeling change is warranted and submitting a statement
detailing the reasons why the application holder does not believe a
change is warranted (a rebuttal statement).
Based on FDA's experience to date with safety labeling changes
requirements under section 505(o)(4), we estimate that approximately 42
application holders will elect to submit approximately one rebuttal
statement each year and that each rebuttal statement will take
approximately 6 hours to prepare.
In addition, in the guidance, FDA states that new labeling prepared
in response to a safety labeling change notification should be
available on the application holder's Web site within 10 calendar days
of approval. FDA estimates that approximately 407 application holders
will post new labeling one time each year in response to a safety
labeling change notification and that the posting of the labeling will
take approximately 4 hours to prepare.
In the Federal Register of September 2, 2015 (80 FR 53161), 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
Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement................................................. 42 1 42 6 252
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of submission Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Posting approved labeling on application holder's Web site......... 407 1 407 4 1,628
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collect of information.
Dated: December 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31696 Filed 12-16-15; 8:45 am]
BILLING CODE 4164-01-P
