82 FR 32832 - Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 136 (July 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 136 (July 18, 2017)
| Page Range | 32832-32834 | |
| FR Document | 2017-15001 |
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)] [Notices] [Pages 32832-32834] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15001] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0920] Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 Health and Diet Survey as used by FDA to gauge and to track consumer attitudes, awareness, knowledge, and behavior [[Page 32833]] regarding various topics related to health, nutrition, physical activity, and product labeling. DATES: Submit either electronic or written comments on the collection of information by September 18, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 18, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2014-N-0920 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. Health and Diet Survey as Used by the Food and Drug Administration OMB Control Number 0910-0545--Extension We are seeking to renew OMB approval of the Health and Diet Survey, which is a voluntary consumer survey intended to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. OMB approved this collection as a generic collection on December 5, 2014. The authority for FDA to collect the information derives from FDA's Commissioner of Food and Drugs authority provided in section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). We will use the Health and Diet Survey findings to test and refine our ideas, but will generally conduct further [[Page 32834]] research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies. This survey has been repeated approximately every 3 to 5 years over the course of the past 3 decades for the purpose of tracking changes and trends in public opinions and consumer behavior, with some new questions added or omitted or partially modified in each iteration in response to emerging and current events or issues. In the next 3 years, we plan to field this survey two to three times. We will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy diets and lifestyles. The information will also help FDA evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health. Description of Respondents: The respondents are adults, age 18 and older, drawn from the 50 States and the District of Columbia. Participation will be voluntary. 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Cognitive interview screener................ 100 1 100 0.08 (5 minutes).......................... 8 Cognitive interview......................... 18 1 18 1......................................... 18 Pretest screener............................ 2,000 1 2,000 0.033 (2 minutes)......................... 66 Pretest..................................... 200 1 200 0.25 (15 minutes)......................... 50 Survey screener............................. 40,000 1 40,000 0.033 (2 minutes)......................... 1,320 Survey...................................... 4,000 1 4,000 0.25 (15 minutes)......................... 1,000 ----------------------------------------------------------------------------------------------------------- Total................................... .............. .............. .............. .......................................... 2,462 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We base our estimate of the number of respondents and the average burden per response on our experience with previous Health and Diet Surveys and we estimate that the burden for this information collection has increased by 580 hours (from 1,882 to 2,462 hours) since the last OMB approval. The increase is due to an expected increase in the number of participants completing the survey screener (from 30,000 to 40,000 participants) and number of participants taking the survey (from 3,000 to 4,000). We will use a cognitive interview screener with 100 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.08 hours) to complete the cognitive interview screener, for a total of 8 hours. We will conduct cognitive interviews with 18 participants. We estimate that it will take a participant approximately 1 hour to complete the interview, for a total of 18 hours. Prior to the administration of the Health and Diet Survey, the Agency plans to conduct a pretest to identify and resolve potential survey administration problems. We will use a pretest screener with 2,000 individuals; we estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the pretest screener, for a total of 66 hours. The pretest will be conducted with 200 participants; we estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 50 hours. We will use a survey screener to select an eligible adult respondent in each household reached by landline telephone numbers to participate in the survey. A total of 40,000 individuals in the 50 states and the District of Columbia will be screened by telephone. We estimate that it will take a respondent 2 minutes (0.033 hours) to complete the screening, for a total of 1,320 hours. We estimate that 4,000 eligible adults will participate in the survey, each taking 15 minutes (0.25 hours), for a total of 1,000 hours. Thus, the total estimated burden is 2,462 hours. We are requesting this burden for unplanned surveys so as not to restrict our ability to gather information on consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. This ability will help the Agency identify and respond to emerging issues in a more timely manner. Dated: July 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15001 Filed 7-17-17; 8:45 am] BILLING CODE 4164-01-P
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Activity FDA Form responses per Total hours
respondents responses per response
respondent
Special drug experience reports, 2301 200 0.57 114 2 ........................... 228
§ 514.80(b)(5)(i).
Submission of advertisements and 2301 200 20.12 4,024 2 ........................... 8,048
promotional labeling,
§ 514.80(b)(5)(ii).
Submission of distributor statements, 2301 190 0.1 19 2 ........................... 38
§ 514.80(b)(5)(iii).
Total ........................................... ........................ ........................ ........................ ........................ .............................. 36,246.25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our reporting estimates on drugs and the number of reports
our experience with adverse event received in the previous 3 years.
reporting for approved new animal
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Recordkeeping, § 510.301 2 ................................................. 5 1 5 4 20
Recordkeeping, 21 U.S.C. 360b(l) and § 514.80(e) 3 .......... 646.70 7.19 4,649.8 14 65,097
Total .............................................................................. ........................ ........................ ........................ ........................ 65,117
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 This estimate includes all recordkeeping by licensed medicated feed manufacturers under § 510.301.
3 This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under § 514.80(e).
We base our recordkeeping estimates be submitted to the Agency. For Form DEPARTMENT OF HEALTH AND
on our experience with adverse event FDA 1932a, we have a fillable electronic HUMAN SERVICES
reporting for approved new animal form available online, which can be
drugs and the number of reports submitted by email to FDA Center for Food and Drug Administration
received in the previous 3 years. Since Veterinary Medicine. We specifically
the consolidation of the 0910–0012 [Docket No. FDA–2014–N–0920]
invite comment from respondents on
collection into this collection in 2004, the utility of these reporting forms. Agency Information Collection
we have included the estimated Electronic adverse event reporting for Activities; Proposed Collection;
recordkeeping burden for medicated approved new animal drugs (including Comment Request; Health and Diet
feed adverse event reports as part of our mandatory reporting under § 514.80(b) Survey, as Used by the Food and Drug
estimate of the recordkeeping burden of and voluntary reporting) has been Administration
all mandatory adverse event reports for approved under OMB control number
new animal drugs. To improve the AGENCY: Food and Drug Administration,
0910–0645. Reporting and
clarity of our estimates we have added HHS.
recordkeeping associated with the index
a row to table 2, on which we separately ACTION: Notice.
report our recordkeeping estimate for of legally marketed unapproved new
medicated feed adverse event reports animal drugs for minor species (21 CFR SUMMARY: The Food and Drug
(20 hours). part 516) is approved under OMB Administration (FDA or Agency) is
The burden of this collection has control number 0910–0620. announcing an opportunity for public
changed. Due to the addition of a new Dated: July 11, 2017. comment on the proposed collection of
row to table 1 and a new row to table Anna K. Abram, certain information by the Agency.
2, there was a slight increase in the Deputy Commissioner for Policy, Planning, Under the Paperwork Reduction Act of
estimated number of reports submitted Legislation, and Analysis. 1995 (PRA), Federal Agencies are
to FDA under total annual responses (by [FR Doc. 2017–14993 Filed 7–17–17; 8:45 am]
required to publish notice in the
7.8 responses). The overall decrease in Federal Register concerning each
BILLING CODE 4164–01–P
burden hours (by 1.75 hours) is due to proposed collection of information,
the normal variation in the submission including each proposed extension of an
sradovich on DSK3GMQ082PROD with NOTICES
of reports to FDA. existing collection of information, and
We continually strive to improve our to allow 60 days for public comment in
systems for collecting and analyzing response to the notice. This notice
drug experience reports and adverse solicits comments on the Health and
event reports. To that end, we have Diet Survey as used by FDA to gauge
developed an electronic submission and to track consumer attitudes,
system by which Form FDA 2301 may awareness, knowledge, and behavior
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![32834 Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
research before making important in each iteration in response to measures of their achievement in
decisions such as adopting new policies emerging and current events or issues. improving public health.
and allocating or redirecting significant In the next 3 years, we plan to field this Description of Respondents: The
resources to support these policies. survey two to three times. We will use respondents are adults, age 18 and
This survey has been repeated the information from the Health and
older, drawn from the 50 States and the
approximately every 3 to 5 years over Diet Survey to evaluate and develop
the course of the past 3 decades for the District of Columbia. Participation will
strategies and programs to encourage
purpose of tracking changes and trends and help consumers adopt healthy diets be voluntary.
in public opinions and consumer and lifestyles. The information will also FDA estimates the burden of this
behavior, with some new questions help FDA evaluate and track consumer collection of information as follows:
added or omitted or partially modified awareness and behavior as outcome
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
Cognitive interview screener .................................... 100 1 100 0.08 (5 minutes) ........ 8
Cognitive interview ................................................... 18 1 18 1 ................................ 18
Pretest screener ....................................................... 2,000 1 2,000 0.033 (2 minutes) ...... 66
Pretest ...................................................................... 200 1 200 0.25 (15 minutes) ...... 50
Survey screener ....................................................... 40,000 1 40,000 0.033 (2 minutes) ...... 1,320
Survey ...................................................................... 4,000 1 4,000 0.25 (15 minutes) ...... 1,000
Total .................................................................. ........................ ........................ ........................ .................................... 2,462
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number respondent in each household reached DEPARTMENT OF HEALTH AND
of respondents and the average burden by landline telephone numbers to HUMAN SERVICES
per response on our experience with participate in the survey. A total of
previous Health and Diet Surveys and 40,000 individuals in the 50 states and Food and Drug Administration
we estimate that the burden for this the District of Columbia will be
information collection has increased by screened by telephone. We estimate that [Docket No. FDA–2010–N–0598]
580 hours (from 1,882 to 2,462 hours) it will take a respondent 2 minutes
since the last OMB approval. The (0.033 hours) to complete the screening, Agency Information Collection
increase is due to an expected increase for a total of 1,320 hours. We estimate Activities; Submission for Office of
in the number of participants Management and Budget Review;
that 4,000 eligible adults will participate
completing the survey screener (from Comment Request; Current Good
in the survey, each taking 15 minutes
30,000 to 40,000 participants) and Manufacturing Practice Regulations for
number of participants taking the survey (0.25 hours), for a total of 1,000 hours. Type A Medicated Articles
(from 3,000 to 4,000). We will use a Thus, the total estimated burden is
cognitive interview screener with 100 2,462 hours. AGENCY: Food and Drug Administration,
individuals to recruit prospective We are requesting this burden for HHS.
interview participants. We estimate that unplanned surveys so as not to restrict ACTION: Notice.
it will take a screener respondent our ability to gather information on
approximately 5 minutes (0.08 hours) to SUMMARY: The Food and Drug
consumer attitudes, awareness,
complete the cognitive interview Administration (FDA or we) is
knowledge, and behavior regarding announcing that a proposed collection
screener, for a total of 8 hours. We will various topics related to health,
conduct cognitive interviews with 18 of information has been submitted to the
nutrition, physical activity, and product Office of Management and Budget
participants. We estimate that it will labeling. This ability will help the
take a participant approximately 1 hour (OMB) for review and clearance under
Agency identify and respond to the Paperwork Reduction Act of 1995.
to complete the interview, for a total of emerging issues in a more timely
18 hours. Prior to the administration of DATES: Fax written comments on the
manner. collection of information by August 17,
the Health and Diet Survey, the Agency
plans to conduct a pretest to identify Dated: July 11, 2017. 2017.
and resolve potential survey Anna K. Abram, ADDRESSES: To ensure that comments on
administration problems. We will use a Deputy Commissioner for Policy, Planning, the information collection are received,
pretest screener with 2,000 individuals; Legislation, and Analysis. OMB recommends that written
we estimate that it will take a [FR Doc. 2017–15001 Filed 7–17–17; 8:45 am] comments be faxed to the Office of
respondent approximately 2 minutes BILLING CODE 4164–01–P
Information and Regulatory Affairs,
(0.033 hours) to complete the pretest OMB, Attn: FDA Desk Officer, FAX:
sradovich on DSK3GMQ082PROD with NOTICES
screener, for a total of 66 hours. The 202–395–7285, or emailed to oira_
pretest will be conducted with 200 submission@omb.eop.gov. All
participants; we estimate that it will comments should be identified with the
take a participant 15 minutes (0.25 OMB control number 0910–0154. Also
hours) to complete the pretest, for a total include the FDA docket number found
of 50 hours. We will use a survey in brackets in the heading of this
screener to select an eligible adult document.
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Document Created: 2018-10-24 11:24:10
Document Modified: 2018-10-24 11:24:10
| 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 September 18, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 32832 |
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