81 FR 75134 - Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 209 (October 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 209 (October 28, 2016)
| Page Range | 75134-75136 | |
| FR Document | 2016-26044 |
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)] [Notices] [Pages 75134-75136] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26044] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0796] Agency Information Collection Activities; Proposed Collection; 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 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 communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health. DATES: Submit either electronic or written comments on the collection of information by December 27, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2013-N-0796 for ``Agency Information Collection Activities; Proposed [[Page 75135]] Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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, when appropriate, and other forms of information technology. 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 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. FDA estimates the burden of this collection of information as follows: [[Page 75136]] Table 1.--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Individual in-depth interviews 360 1 360 .75 (45 minutes) 270 General public focus group 144 1 144 1.5 hours....... 216 interviews. Intercept interviews: Central 200 1 200 .25 (15 minutes. 50 location. Intercept interviews: 4,000 1 4,000 .08 (5 minutes). 320 Telephone. 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 144 1 144 1.5 hours....... 216 interviews. --------------------------------------------------------------------------------- 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: October 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26044 Filed 10-27-16; 8:45 am] BILLING CODE 4164-01-P
![75134 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR Section Form FDA No. responses per Total hours 10
respondents responses per response
respondent
Total ............................................ ........................ ........................ ........................ ........................ .............................. 333,949
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 640.17, 640.25(c), 640.56(c), 640.74(b)(2),
660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 601.93(b)(3), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65.
4 The reporting requirements under §§ 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under
§ 601.12(c).
6 The reporting requirement under § 601.12(a)(2) is included in the estimate under § 601.12(d).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
8 The reporting requirement under §§ 601.12(a)(4) and 601.14 is included in the estimate under § 601.12(f)(3).
9 The reporting requirement under § 601.94 is included in the estimate under § 601.45.
10 The numbers in this column have been rounded to the nearest whole number.
Under table 2, the estimated recordkeeping requirements associated
recordkeeping burden of 1 hour is based with the AER system.
on previous estimates for the
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Annual
Number of Total annual Average burden
21 CFR Section disclosures per Total hours 2
respondents disclosures per disclosure
respondent
601.6(a) ...................................................................... 1 20 20 0.33 7
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The numbers in this column have been rounded to the nearest whole number.
Dated: October 25, 2016. public comment in response to the confidential business information, such
Leslie Kux, notice. This notice solicits comments on as a manufacturing process. Please note
Associate Commissioner for Policy. communication studies involving that if you include your name, contact
[FR Doc. 2016–26064 Filed 10–27–16; 8:45 am] medical devices and radiation-emitting information, or other information that
BILLING CODE 4164–01–P products regulated by FDA. This identifies you in the body of your
information will be used to explore comments, that information will be
concepts of interest and assist in the posted on http://www.regulations.gov.
DEPARTMENT OF HEALTH AND development and modification of • If you want to submit a comment
HUMAN SERVICES communication messages and with confidential information that you
campaigns to fulfill the Agency’s do not wish to be made available to the
Food and Drug Administration mission to protect the public health. public, submit the comment as a
[Docket No. FDA–2013–N–0796] DATES: Submit either electronic or written/paper submission and in the
written comments on the collection of manner detailed (see ‘‘Written/Paper
Agency Information Collection information by December 27, 2016. Submissions’’ and ‘‘Instructions’’).
Activities; Proposed Collection; ADDRESSES: You may submit comments Written/Paper Submissions
Comment Request; Testing as follows:
Communications on Medical Devices Submit written/paper submissions as
and Radiation-Emitting Products Electronic Submissions follows:
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, Submit electronic comments in the written/paper submissions): Division of
HHS. following way: Dockets Management (HFA–305), Food
ACTION: Notice. • Federal eRulemaking Portal: http:// and Drug Administration, 5630 Fishers
www.regulations.gov. Follow the Lane, Rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug instructions for submitting comments. • For written/paper comments
Administration (FDA) is announcing an Comments submitted electronically, submitted to the Division of Dockets
opportunity for public comment on the including attachments, to http:// Management, FDA will post your
proposed collection of certain www.regulations.gov will be posted to comment, as well as any attachments,
information by the Agency. Under the the docket unchanged. Because your
mstockstill on DSK3G9T082PROD with NOTICES
except for information submitted,
Paperwork Reduction Act of 1995 (the comment will be made public, you are marked and identified, as confidential,
PRA), Federal Agencies are required to solely responsible for ensuring that your if submitted as detailed in
publish notice in the Federal Register comment does not include any ‘‘Instructions.’’
concerning each proposed collection of confidential information that you or a Instructions: All submissions received
information, including each proposed third party may not wish to be posted, must include the Docket No. FDA–
extension of an existing collection of such as medical information, your or 2013–N–0796 for ‘‘Agency Information
information, and to allow 60 days for anyone else’s Social Security number, or Collection Activities; Proposed
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![75136 Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent
Individual in-depth interviews ............................... 360 1 360 .75 (45 minutes) ............ 270
General public focus group interviews ................. 144 1 144 1.5 hours ....................... 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 hours ....................... 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: October 21, 2016. Electronic Submissions if submitted as detailed in
Leslie Kux,
Submit electronic comments in the ‘‘Instructions.’’
Associate Commissioner for Policy. following way: Instructions: All submissions received
[FR Doc. 2016–26044 Filed 10–27–16; 8:45 am] • Federal eRulemaking Portal: http:// must include the Docket No. FDA–
BILLING CODE 4164–01–P www.regulations.gov. Follow the 2009–D–0524 for ‘‘Listing of Ingredients
instructions for submitting comments. in Tobacco Products.’’ Received
Comments submitted electronically, comments will be placed in the docket
DEPARTMENT OF HEALTH AND including attachments, to http:// and, except for those submitted as
HUMAN SERVICES www.regulations.gov will be posted to ‘‘Confidential Submissions,’’ publicly
the docket unchanged. Because your viewable at http://www.regulations.gov
Food and Drug Administration or at the Division of Dockets
comment will be made public, you are
solely responsible for ensuring that your Management between 9 a.m. and 4 p.m.,
[Docket No. FDA–2009–D–0524] comment does not include any Monday through Friday.
confidential information that you or a • Confidential Submissions—To
Listing of Ingredients in Tobacco third party may not wish to be posted, submit a comment with confidential
Products; Revised Draft Guidance for such as medical information, your or information that you do not wish to be
Industry; Availability anyone else’s Social Security number, or made publicly available, submit your
confidential business information, such comments only as a written/paper
AGENCY: Food and Drug Administration,
as a manufacturing process. Please note submission. You should submit two
HHS.
that if you include your name, contact copies total. One copy will include the
ACTION: Notice of availability. information, or other information that information you claim to be confidential
identifies you in the body of your with a heading or cover note that states
SUMMARY: The Food and Drug comments, that information will be ‘‘THIS DOCUMENT CONTAINS
Administration (FDA or we) is posted on http://www.regulations.gov. CONFIDENTIAL INFORMATION.’’ The
announcing the availability of a revised • If you want to submit a comment Agency will review this copy, including
draft guidance for industry entitled with confidential information that you the claimed confidential information, in
‘‘Listing of Ingredients in Tobacco do not wish to be made available to the its consideration of comments. The
Products.’’ The revised draft guidance public, submit the comment as a second copy, which will have the
document is intended to assist persons written/paper submission and in the claimed confidential information
making tobacco product ingredient manner detailed (see ‘‘Written/Paper redacted/blacked out, will be available
submissions to FDA as required by the Submissions’’ and ‘‘Instructions’’). for public viewing and posted on http://
Family Smoking Prevention and www.regulations.gov. Submit both
Tobacco Control Act (Tobacco Control Written/Paper Submissions copies to the Division of Dockets
Act). Submit written/paper submissions as Management. If you do not wish your
follows: name and contact information to be
DATES: Although you can comment on • Mail/Hand delivery/Courier (for made publicly available, you can
any guidance at any time (see 21 CFR written/paper submissions): Division of provide this information on the cover
10.115(g)(5)), to ensure that the Agency Dockets Management (HFA–305), Food sheet and not in the body of your
considers your comment on this revised and Drug Administration, 5630 Fishers comments and you must identify this
mstockstill on DSK3G9T082PROD with NOTICES
draft guidance before it begins work on Lane, Rm. 1061, Rockville, MD 20852. information as ‘‘confidential.’’ Any
the final version of the guidance, submit • For written/paper comments information marked as ‘‘confidential’’
either electronic or written comments submitted to the Division of Dockets will not be disclosed except in
on the revised draft guidance by Management, FDA will post your accordance with 21 CFR 10.20 and other
November 28, 2016. comment, as well as any attachments, applicable disclosure law. For more
ADDRESSES: You may submit comments except for information submitted, information about FDA’s posting of
as follows: marked and identified, as confidential, comments to public dockets, see 80 FR
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Document Created: 2018-02-13 16:40:09
Document Modified: 2018-02-13 16:40:09
| 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 | Submit either electronic or written comments on the collection of information by December 27, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 75134 |
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