82 FR 13812 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13812-13813 | |
| FR Document | 2017-05097 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13812-13813] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![13812 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correc- 1,875 365 684,375 0.1 (6 minutes) ..... 68,438
tion records for Sanitation Standard Operating Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b) and (c)—Require written hazard 2,300 1.1 2,530 20 ......................... 50,600
analysis of food hazards.
120.8(a) and 20.12(a)(3), (b), and (c)—Require written HACCP plan .......... 1,560 1.1 1716 60 ......................... 102,960
120.8(b)(7) and 120.12(a)(4)(i) and (b)—Require a recordkeeping system 1,450 14,600 21,170,000 0.01 (1 minute) ..... 211,700
that documents monitoring of the critical control points and other meas-
urements as prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) and (b)—Require that all corrective actions 1,840 12 22,080 0.1 (6 minutes) ..... 2,208
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 1,840 52 95,680 0.1 (6 minutes) ..... 9,568
showing verification activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)—Require records showing validation 1,840 1 1,840 4 ........................... 7,360
activities associated with the HACCP system.
120.11(c) and 120.12(a)(5) and (b)—Require documentation of revalidation 1,840 1 1,840 4 ........................... 7,360
of the hazard analysis upon any changes that might affect the original
hazard analysis (applies when a firm does not have a HACCP plan be-
cause 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 308 1 308 4 ........................... 1,232
written procedures to ensure that the juice is processed in accordance
with our regulations in part 120.
Total ........................................................................................................ ........................ ........................ ........................ ............................... 461,426
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the DEPARTMENT OF HEALTH AND and Drug Administration, Three White
total annual recordkeeping burden of HUMAN SERVICES Flint North 10A–12M, 11601
our regulations in part 120. We base our Landsdown St., North Bethesda, MD
estimate of the average burden per Food and Drug Administration 20852, PRAStaff@fda.hhs.gov.
recordkeeping on our experience with [Docket No. FDA–2013–N–0796] SUPPLEMENTARY INFORMATION: In
the application of HACCP principles in compliance with 44 U.S.C. 3507, FDA
food processing. We base our estimate of Agency Information Collection has submitted the following proposed
the number of recordkeepers on our Activities; Submission for Office of collection of information to OMB for
estimate of the total number of juice Management and Budget Review; review and clearance.
manufacturing plants affected by the Comment Request; Testing
Communications on Medical Devices Testing Communications on Medical
regulations (plants identified in our Devices and Radiation-Emitting
official establishment inventory plus and Radiation-Emitting Products
Products—OMB Control Number 0910–
very small apple juice and very small AGENCY: Food and Drug Administration, 0678—Extension
orange juice manufacturers). These HHS. FDA is authorized by section
estimates assume that every processor ACTION: Notice. 1003(d)(2)(D) of the Federal Food, Drug,
will prepare sanitary standard operating and Cosmetic Act (21 U.S.C.
procedures and an HACCP plan and SUMMARY: The Food and Drug
Administration (FDA) is announcing 393(d)(2)(D)) to conduct educational
maintain the associated monitoring and public information programs
records, and that every importer will that a proposed collection of
information has been submitted to the relating to the safety of regulated
require product safety specifications. In medical devices and radiation-emitting
Office of Management and Budget
fact, there are likely to be some small (OMB) for review and clearance under products. FDA must conduct needed
number of juice processors that, based the Paperwork Reduction Act of 1995. research to ensure that such programs
upon their hazard analysis, determine have the highest likelihood of being
DATES: Fax written comments on the
that they are not required to have an collection of information by April 14, effective. Improving communications
HACCP plan under these regulations. 2017. about medical devices and radiation
Dated: March 9, 2017. emitting products will involve many
ADDRESSES: To ensure that comments on research methods, including individual
Leslie Kux, the information collection are received, in-depth interviews, mall-intercept
Associate Commissioner for Policy. OMB recommends that written interviews, focus groups, self-
[FR Doc. 2017–05105 Filed 3–14–17; 8:45 am] comments be faxed to the Office of administered surveys, gatekeeper
BILLING CODE 4164–01–P
Information and Regulatory Affairs, reviews, and omnibus telephone
OMB, Attn: FDA Desk Officer, FAX: surveys.
202–395–7285, or emailed to oira_
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
The information collected will serve
submission@omb.eop.gov. All three major purposes. First, as formative
comments should be identified with the research it will provide critical
OMB control number 0910–0678. Also knowledge needed about target
include the FDA docket number found audiences to develop messages and
in brackets in the heading of this campaigns about medical device and
document. radiation-emitting product use.
FOR FURTHER INFORMATION CONTACT: FDA Knowledge of consumer and health care
PRA Staff, Office of Operations, Food professional decision making processes
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![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13813
will provide the better understanding of audience will allow FDA to refine hours). FDA estimates the burden of this
target audiences that FDA needs to messages while still in the collection of information based on prior
design effective communication developmental stage. Respondents will recent experience with the various types
strategies, messages, and labels. These be asked to give their reaction to the of data collection methods described
communications will aim to improve messages in either individual or group earlier. FDA is requesting this burden so
public understanding of the risks and settings. as not to restrict the Agency’s ability to
benefits of using medical devices and Third, as evaluative research, it will gather information on public sentiment
radiation-emitting products by allow FDA to ascertain the effectiveness for its proposals in its regulatory and
providing users with a better context in of the messages and the distribution communications programs.
which to place risk information more method of these messages in achieving
In the Federal Register of October 28,
the objectives of the message campaign.
completely. 2016 (81 FR 75134), FDA published a
Evaluation of campaigns is a vital link
Second, as initial testing, it will allow in continuous improvement of 60-day notice requesting public
FDA to assess the potential effectiveness communications at FDA. comment on the proposed collection of
of messages and materials in reaching Annually, FDA projects about 30 information. No comments were
and successfully communicating with studies using a variety of research received.
their intended audiences. Testing methods and lasting an average of 0.17 FDA estimates the burden of this
messages with a sample of the target hours each (varying from 0.08 to 1.5 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
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. that a proposed collection of SUPPLEMENTARY INFORMATION: In
Leslie Kux, information has been submitted to the compliance with 44 U.S.C. 3507, FDA
Associate Commissioner for Policy. Office of Management and Budget has submitted the following proposed
[FR Doc. 2017–05097 Filed 3–14–17; 8:45 am] (OMB) for review and clearance under collection of information to OMB for
BILLING CODE 4164–01–P
the Paperwork Reduction Act of 1995. review and clearance.
DATES: Fax written comments on the
Recommended Glossary and
collection of information by April 14, Educational Outreach To Support Use
DEPARTMENT OF HEALTH AND 2017. of Symbols on Labels and in Labeling
HUMAN SERVICES ADDRESSES: To ensure that comments on of In Vitro Diagnostic Devices Intended
Food and Drug Administration the information collection are received, for Professional Use
OMB recommends that written
[Docket No. FDA–2013–N–1089] comments be faxed to the Office of OMB Control Number 0910–0553—
Information and Regulatory Affairs, Extension
Agency Information Collection OMB, Attn: FDA Desk Officer, FAX: Section 502 of the Federal Food, Drug,
Activities; Submission for Office of (202) 395–7285, or emailed to oira_ and Cosmetic Act (the FD&C Act) (21
Management and Budget Review; submission@omb.eop.gov. All U.S.C. 352), among other things,
Comment Request; Recommended comments should be identified with the establishes requirements for the label or
Glossary and Educational Outreach To OMB control number 0910–0553. Also labeling of a medical device to avoid
Support Use of Symbols on Labels and include the FDA docket number found
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
misbranding. Section 351 of the Public
in Labeling of In Vitro Diagnostic in brackets in the heading of this Health Service Act (the PHS Act) (42
Devices Intended for Professional Use document. U.S.C. 262) establishes requirements
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA that manufacturers of biological
HHS. PRA Staff, Office of Operations, Food products must submit a license
ACTION: Notice. and Drug Administration, Three White application for FDA review and
Flint North 10A–12M, 11601 approval prior to marketing a biological
SUMMARY: The Food and Drug Landsdown St., North Bethesda, MD product for introduction into interstate
Administration (FDA) is announcing 20852, PRAStaff@fda.hhs.gov. commerce.
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Document Created: 2017-03-15 06:04:38
Document Modified: 2017-03-15 06:04:38
| 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 April 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 13812 |
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