Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System, 14138-14139 [2015-06118]
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14138
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
TABLE 1—ESTIMATED HOURLY RECORDKEEPING BURDEN—Continued
Number of
recordkeepers
21 CFR Section
14 ......................
First year
frequency of
recordkeeping
Total
records
Hours per
record
Total
hours
17 ......................
18 ......................
19 ......................
20 ......................
21 ......................
52
156
0.25
39
1
12
12
0.25
3
2
1
2
2
4
2
52
104
0.15
15.6
2
52
104
0.15
15.6
2
52
104
0.15
15.6
3
1
3
8
24
3
52
156
4
624
..........................
..........................
................
................
6,328.06
Total Recordkeeping Burden ...................................
16 ......................
3
Total Recurring Recordkeeping Burden ...................
15 ......................
Controls to Prevent Adulteration From Microorganisms
106.55(d),
106.100(e)(5)(ii),
and
106.100(f)(7).
Controls to Prevent Adulteration During Packaging
and Labeling of Infant Formula 106.60(c).
General Quality Control—Testing 106.91(b)(1),
106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1), 106.91(d),
and 106.100(e)(5)(i).
General Quality Control 106.91(b)(2) 106.91(d),
and 106.100(e)(5)(i).
General Quality Control 106.91(b)(3) 106.91(d),
and 106.100(e)(5)(i).
Audit Plans and Procedures 106.94—Ongoing review and updating of Audits.
Audit Plans and Procedures 106.94—Regular Audits.
..........................
..........................
................
................
25,648.06
1 As
noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
2 As noted previously in the document, the burden for making and maintaining such records is expected to occur once every 4 years. The total
hours column reflects the total number of hours averaged over the 4-year period.
III. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Zink, Don. Statement of Donald L. Zink,
Ph.D.: Infant Formula Manufacturing
Practices, 2013.
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06117 Filed 3–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0197]
mstockstill on DSK4VPTVN1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Emergency
Shortages Data Collection System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
VerDate Sep<11>2014
19:00 Mar 17, 2015
Jkt 235001
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Emergency Shortages Data
Collection System.
DATES: Submit either electronic or
written comments on the collection of
information by May 18, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
E:\FR\FM\18MRN1.SGM
18MRN1
14139
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
when appropriate, and other forms of
information technology.
Emergency Shortages Data Collection
System—Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act
(OMB Control Number 0910–0491)—
(Extension)
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is
authorized to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader
counterterrorism and emergency
preparedness activities, FDA’s Center
for Devices and Radiological Health
(CDRH) began developing operational
plans and interventions that would
enable CDRH to anticipate and respond
to medical device shortages that might
arise in the context of Federally
declared disasters/emergencies or
regulatory actions. In particular, CDRH
identified the need to acquire and
maintain detailed data on domestic
inventory, manufacturing capabilities,
distribution plans, and raw material
constraints for medical devices that
would be in high demand, and/or would
be vulnerable to shortages in specific
disaster/emergency situations or
following specific regulatory actions.
Such data could support prospective
risk assessment, help inform risk
mitigation strategies, and support realtime decision-making by the
Department of Health and Human
Services during actual emergencies or
emergency preparedness exercises.
FDA developed ‘‘The Emergency
Medical Device Shortages Program
Survey’’ in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored was
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to the ESDCS is
restricted to members of the CDRH
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to two senior managers. Further,
the data are used by this defined group
only for decision making and planning
in the context of a Federally declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
non-disaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices tracked in the ESDCS.
In this initial call, the EST member
describes the intent and goals of the
data collection effort and makes the
specific data request. After the initial
call, one or more additional follow-up
calls and/or electronic mail
correspondence may be required to
verify/validate data sent from the
manufacturer, confirm receipt, and/or
request additional detail. Although the
regulatory officer is the agent who the
EST member initially contacts,
regulatory officers may designate an
alternate representative within their
organization to correspond subsequently
with the CDRH EST member who is
collecting or verifying/validating the
data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities, and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. The EST
makes such updates on a regular basis,
but makes efforts to limit the frequency
of outreach to a specific manufacturer to
no more than every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/FD&C act section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(hours)
Total hours
Emergency Shortages Data Collection System (903(d)(2)) ....................
125
3
375
0.5
188
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
table 1 of this document on past
experience with direct contact with the
medical device manufacturers and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year either to obtain primary data or
to verify/validate data. Because the
requested data represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
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19:00 Mar 17, 2015
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request will not exceed 30 minutes per
request cycle.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–06118 Filed 3–17–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
[Docket No. FDA–2015–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Cardiovascular and Renal Drugs
Advisory Committee. This meeting was
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14138-14139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06118]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0197]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Emergency Shortages Data Collection System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the Emergency Shortages Data
Collection System.
DATES: Submit either electronic or written comments on the collection
of information by May 18, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques,
[[Page 14139]]
when appropriate, and other forms of information technology.
Emergency Shortages Data Collection System--Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)--
(Extension)
Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and
Drugs is authorized to implement general powers (including conducting
research) to carry out effectively the mission of FDA. Subsequent to
the events of September 11, 2001, and as part of broader
counterterrorism and emergency preparedness activities, FDA's Center
for Devices and Radiological Health (CDRH) began developing operational
plans and interventions that would enable CDRH to anticipate and
respond to medical device shortages that might arise in the context of
Federally declared disasters/emergencies or regulatory actions. In
particular, CDRH identified the need to acquire and maintain detailed
data on domestic inventory, manufacturing capabilities, distribution
plans, and raw material constraints for medical devices that would be
in high demand, and/or would be vulnerable to shortages in specific
disaster/emergency situations or following specific regulatory actions.
Such data could support prospective risk assessment, help inform risk
mitigation strategies, and support real-time decision-making by the
Department of Health and Human Services during actual emergencies or
emergency preparedness exercises.
FDA developed ``The Emergency Medical Device Shortages Program
Survey'' in 2002 to support the acquisition of such data from medical
device manufacturers. In 2004, CDRH changed the process for the data
collection, and the electronic database in which the data were stored
was formally renamed the ``Emergency Shortages Data Collection System''
(ESDCS). Recognizing that some of the data collected may be
commercially confidential, access to the ESDCS is restricted to members
of the CDRH Emergency Shortage Team (EST) and senior management with a
need-to-know. At this time, the need-to-know senior management
personnel are limited to two senior managers. Further, the data are
used by this defined group only for decision making and planning in the
context of a Federally declared disaster/emergency, an official
emergency preparedness exercise, or a potential public health risk
posed by non-disaster-related device shortage.
The data procurement process consists of an initial scripted
telephone call to a regulatory officer at a registered manufacturer of
one or more key medical devices tracked in the ESDCS. In this initial
call, the EST member describes the intent and goals of the data
collection effort and makes the specific data request. After the
initial call, one or more additional follow-up calls and/or electronic
mail correspondence may be required to verify/validate data sent from
the manufacturer, confirm receipt, and/or request additional detail.
Although the regulatory officer is the agent who the EST member
initially contacts, regulatory officers may designate an alternate
representative within their organization to correspond subsequently
with the CDRH EST member who is collecting or verifying/validating the
data.
Because of the dynamic nature of the medical device industry,
particularly with respect to specific product lines, manufacturing
capabilities, and raw material/subcomponent sourcing, it is necessary
to update the data in the ESDCS at regular intervals. The EST makes
such updates on a regular basis, but makes efforts to limit the
frequency of outreach to a specific manufacturer to no more than every
4 months.
The ESDCS will only include those medical devices for which there
will likely be high demand during a specific emergency/disaster, or for
which there are sufficiently small numbers of manufacturers such that
disruption of manufacture or loss of one or more of these manufacturers
would create a shortage.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of Average
Number of responses Total annual burden per
Activity/FD&C act section respondents per responses response Total hours
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Emergency Shortages Data Collection System 125 3 375 0.5 188
(903(d)(2))..............................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA based the burden estimates in table 1 of this document on past
experience with direct contact with the medical device manufacturers
and anticipated changes in the medical device manufacturing patterns
for the specific devices being monitored. FDA estimates that
approximately 125 manufacturers would be contacted by telephone and/or
electronic mail 3 times per year either to obtain primary data or to
verify/validate data. Because the requested data represent data
elements that are monitored or tracked by manufacturers as part of
routine inventory management activities, it is anticipated that for
most manufacturers, the estimated time required of manufacturers to
complete the data request will not exceed 30 minutes per request cycle.
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06118 Filed 3-17-15; 8:45 am]
BILLING CODE 4164-01-P
