Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products, 13812-13813 [2017-05097]
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Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correction records for Sanitation Standard Operating Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b) and (c)—Require written hazard
analysis of food hazards.
120.8(a) and 20.12(a)(3), (b), and (c)—Require written HACCP plan ..........
120.8(b)(7) and 120.12(a)(4)(i) and (b)—Require a recordkeeping system
that documents monitoring of the critical control points and other measurements as prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) and (b)—Require that all corrective actions
taken in response to a deviation from a critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) and (b)—Require records
showing verification activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)—Require records showing validation
activities associated with the HACCP system.
120.11(c) and 120.12(a)(5) and (b)—Require documentation of revalidation
of the hazard analysis upon any changes that might affect the original
hazard analysis (applies when a firm does not have a HACCP plan because the original hazard analysis did not reveal hazards likely to occur).
120.14(a)(2), (c), and (d) and 120.12(b)—Require that juice importers have
written procedures to ensure that the juice is processed in accordance
with our regulations in part 120.
Total ........................................................................................................
1 There
Average
burden per
recordkeeping
Total annual
records
Total hours
1,875
365
684,375
0.1 (6 minutes) .....
68,438
2,300
1.1
2,530
20 .........................
50,600
1,560
1,450
1.1
14,600
1716
21,170,000
60 .........................
0.01 (1 minute) .....
102,960
211,700
1,840
12
22,080
0.1 (6 minutes) .....
2,208
1,840
52
95,680
0.1 (6 minutes) .....
9,568
1,840
1
1,840
4 ...........................
7,360
1,840
1
1,840
4 ...........................
7,360
308
1
308
4 ...........................
1,232
........................
........................
........................
...............................
461,426
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the
total annual recordkeeping burden of
our regulations in part 120. We base our
estimate of the average burden per
recordkeeping on our experience with
the application of HACCP principles in
food processing. We base our estimate of
the number of recordkeepers on our
estimate of the total number of juice
manufacturing plants affected by the
regulations (plants identified in our
official establishment inventory plus
very small apple juice and very small
orange juice manufacturers). These
estimates assume that every processor
will prepare sanitary standard operating
procedures and an HACCP plan and
maintain the associated monitoring
records, and that every importer will
require product safety specifications. In
fact, there are likely to be some small
number of juice processors that, based
upon their hazard analysis, determine
that they are not required to have an
HACCP plan under these regulations.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05105 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
Number of
records per
recordkeeper
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 April 14,
2017.
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 0910–0678. 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
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 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.
Testing Communications on Medical
Devices and Radiation-Emitting
Products—OMB Control Number 0910–
0678—Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiation
emitting products will involve many
research methods, including individual
in-depth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about medical device and
radiation-emitting product use.
Knowledge of consumer and health care
professional decision making processes
E:\FR\FM\15MRN1.SGM
15MRN1
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
will provide the better understanding of
target audiences that FDA needs to
design effective communication
strategies, messages, and labels. These
communications will aim to improve
public understanding of the risks and
benefits of using medical devices and
radiation-emitting products by
providing users with a better context in
which to place risk information more
completely.
Second, as initial testing, it will allow
FDA to assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
in continuous improvement of
communications at FDA.
Annually, FDA projects about 30
studies using a variety of research
methods and lasting an average of 0.17
hours each (varying from 0.08 to 1.5
13813
hours). FDA estimates the burden of this
collection of information based on prior
recent experience with the various types
of data collection methods described
earlier. FDA is requesting this burden so
as not to restrict the Agency’s ability to
gather information on public sentiment
for its proposals in its regulatory and
communications programs.
In the Federal Register of October 28,
2016 (81 FR 75134), 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
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Individual in-depth interviews .......................................
General public focus group interviews .........................
Intercept interviews: Central location ...........................
Intercept interviews: Telephone ...................................
Self-administered surveys ............................................
Gatekeeper reviews .....................................................
Omnibus surveys ..........................................................
360
144
200
4,000
2,400
400
1,200
1
1
1
1
1
1
1
360
144
200
4,000
2,400
400
1,200
.75 (45 minutes) ....
1.5 .........................
.25 (15 minutes) ....
.08 (5 minutes) ......
.25 (15 minutes) ....
.5 (30 minutes) ......
.17 (10 minutes) ....
270
216
50
320
600
200
204
Total (general public) ............................................
8,704
........................
........................
...............................
1,860
Physician focus group interviews .................................
144
1
144
1.5 .........................
216
Total (physician) ....................................................
144
........................
........................
...............................
216
Total (overall) .................................................
8,848
........................
........................
...............................
2,076
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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 April 14,
2017.
[FR Doc. 2017–05097 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
[Docket No. FDA–2013–N–1089]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recommended
Glossary and Educational Outreach To
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
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 0910–0553. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Recommended Glossary and
Educational Outreach To Support Use
of Symbols on Labels and in Labeling
of In Vitro Diagnostic Devices Intended
for Professional Use
OMB Control Number 0910–0553—
Extension
Section 502 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 352), among other things,
establishes requirements for the label or
labeling of a medical device to avoid
misbranding. Section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262) establishes requirements
that manufacturers of biological
products must submit a license
application for FDA review and
approval prior to marketing a biological
product for introduction into interstate
commerce.
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13812-13813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05097]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0796]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Testing
Communications on Medical Devices and Radiation-Emitting Products
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 April
14, 2017.
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 0910-0678.
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, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Testing Communications on Medical Devices and Radiation-Emitting
Products--OMB Control Number 0910-0678--Extension
FDA is authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational
and public information programs relating to the safety of regulated
medical devices and radiation-emitting products. FDA must conduct
needed research to ensure that such programs have the highest
likelihood of being effective. Improving communications about medical
devices and radiation emitting products will involve many research
methods, including individual in-depth interviews, mall-intercept
interviews, focus groups, self-administered surveys, gatekeeper
reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First,
as formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about medical device
and radiation-emitting product use. Knowledge of consumer and health
care professional decision making processes
[[Page 13813]]
will provide the better understanding of target audiences that FDA
needs to design effective communication strategies, messages, and
labels. These communications will aim to improve public understanding
of the risks and benefits of using medical devices and radiation-
emitting products by providing users with a better context in which to
place risk information more completely.
Second, as initial testing, it will allow FDA to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. Testing
messages with a sample of the target audience will allow FDA to refine
messages while still in the developmental stage. Respondents will be
asked to give their reaction to the messages in either individual or
group settings.
Third, as evaluative research, it will allow FDA to ascertain the
effectiveness of the messages and the distribution method of these
messages in achieving the objectives of the message campaign.
Evaluation of campaigns is a vital link in continuous improvement of
communications at FDA.
Annually, FDA projects about 30 studies using a variety of research
methods and lasting an average of 0.17 hours each (varying from 0.08 to
1.5 hours). FDA estimates the burden of this collection of information
based on prior recent experience with the various types of data
collection methods described earlier. FDA is requesting this burden so
as not to restrict the Agency's ability to gather information on public
sentiment for its proposals in its regulatory and communications
programs.
In the Federal Register of October 28, 2016 (81 FR 75134), 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
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individual in-depth interviews................ 360 1 360 .75 (45 minutes)........................ 270
General public focus group interviews......... 144 1 144 1.5..................................... 216
Intercept interviews: Central location........ 200 1 200 .25 (15 minutes)........................ 50
Intercept interviews: Telephone............... 4,000 1 4,000 .08 (5 minutes)......................... 320
Self-administered surveys..................... 2,400 1 2,400 .25 (15 minutes)........................ 600
Gatekeeper reviews............................ 400 1 400 .5 (30 minutes)......................... 200
Omnibus surveys............................... 1,200 1 1,200 .17 (10 minutes)........................ 204
---------------------------------------------------------------------------------------------------------
Total (general public).................... 8,704 .............. .............. ........................................ 1,860
---------------------------------------------------------------------------------------------------------
Physician focus group interviews.............. 144 1 144 1.5..................................... 216
---------------------------------------------------------------------------------------------------------
Total (physician)......................... 144 .............. .............. ........................................ 216
---------------------------------------------------------------------------------------------------------
Total (overall)....................... 8,848 .............. .............. ........................................ 2,076
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05097 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P
