82 FR 52053 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52053-52055 | |
| FR Document | 2017-24409 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52053-52055] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24409] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0920] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 we) 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. [[Page 52054]] DATES: Fax written comments on the collection of information by December 11, 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 0910-0545. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [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. 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 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. In the Federal Register of July 18, 2017 (82 FR 32832), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received no comments. 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 .08.................................... 8 (5 minutes)............................ Cognitive interview............................ 18 1 18 1...................................... 18 Pretest screener............................... 2,000 1 2,000 .033 (2 minutes)....................... 66 Pretest........................................ 200 1 200 .25 (15 minutes)....................... 50 Survey screener................................ 40,000 1 40,000 .033 (2 minutes)....................... 1,320 Survey......................................... 4,000 1 4,000 .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 [[Page 52055]] Agency identify and respond to emerging issues in a more timely manner. Dated: November 6, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-24409 Filed 11-8-17; 8:45 am] BILLING CODE 4164-01-P
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written/paper submission and in the electronic and written/paper comments provides multiple areas of clarification
manner detailed (see ‘‘Written/Paper received, go to https:// throughout the document.
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the This guidance is being issued
docket number, found in brackets in the consistent with FDA’s good guidance
Written/Paper Submissions
heading of this document, into the practices regulation (21 CFR 10.115).
Submit written/paper submissions as ‘‘Search’’ box and follow the prompts The guidance represents the current
follows: and/or go to the Dockets Management thinking of FDA on evaluating drug
• Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, effects on the ability to operate a motor
written/paper submissions): Dockets Rockville, MD 20852. vehicle. It does not establish any rights
Management Staff (HFA–305), Food and You may submit comments on any for any person and is not binding on
Drug Administration, 5630 Fishers guidance at any time (see 21 CFR FDA or the public. You can use an
Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). alternative approach if it satisfies the
• For written/paper comments Submit written requests for single requirements of the applicable statutes
submitted to the Dockets Management copies of this guidance to the Division and regulations. This guidance is not
Staff, FDA will post your comment, as of Drug Information, Center for Drug subject to Executive Order 12866.
well as any attachments, except for Evaluation and Research, Food and
information submitted, marked and II. The Paperwork Reduction Act of
Drug Administration, 10001 New
identified, as confidential, if submitted 1995
Hampshire Ave., Hillandale Building,
as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– This guidance refers to previously
Instructions: All submissions received
0002. Send one self-addressed adhesive approved collections of information that
must include the Docket No. FDA–
label to assist that office in processing are subject to review by the Office of
2014–D–2300 for ‘‘Evaluating Drug
your requests. See the SUPPLEMENTARY Management and Budget (OMB) under
Effects on the Ability to Operate a Motor
INFORMATION section for electronic the Paperwork Reduction Act of 1995
Vehicle.’’ Received comments will be
access to the guidance document. (44 U.S.C. 3501–3520). The collections
placed in the docket and, except for
FOR FURTHER INFORMATION CONTACT: of information in 21 CFR parts 312 and
those submitted as ‘‘Confidential
Naomi Lowy, Center for Drug 314 have been approved under OMB
Submissions,’’ publicly viewable at
Evaluation and Research, Food and control numbers 0910–0014 and 0910–
https://www.regulations.gov or at the
Drug Administration, 10903 New 0001, respectively.
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 22, Rm. 4204, III. Electronic Access
Friday. Silver Spring, MD 20993–0002, 301–
Persons with access to the internet
• Confidential Submissions—To 796–0692.
may obtain the guidance at either
submit a comment with confidential SUPPLEMENTARY INFORMATION:
https://www.fda.gov/Drugs/Guidance
information that you do not wish to be
I. Background ComplianceRegulatoryInformation/
made publicly available, submit your
FDA is announcing the availability of Guidances/default.htm or https://
comments only as a written/paper
a guidance for industry entitled www.regulations.gov.
submission. You should submit two
copies total. One copy will include the ‘‘Evaluating Drug Effects on the Ability Dated: November 3, 2017.
information you claim to be confidential to Operate a Motor Vehicle.’’ The Anna K. Abram,
with a heading or cover note that states purpose of this guidance is to assist Deputy Commissioner for Policy, Planning,
‘‘THIS DOCUMENT CONTAINS sponsors in the evaluation of the effects Legislation, and Analysis.
CONFIDENTIAL INFORMATION.’’ The of psychoactive drugs on the ability to [FR Doc. 2017–24367 Filed 11–8–17; 8:45 am]
Agency will review this copy, including operate a motor vehicle. BILLING CODE 4164–01–P
the claimed confidential information, in Driving is a complex activity
its consideration of comments. The involving a wide range of cognitive,
second copy, which will have the perceptual, and motor activities that can DEPARTMENT OF HEALTH AND
claimed confidential information be adversely affected by therapeutic HUMAN SERVICES
redacted/blacked out, will be available drugs. Reducing the incidence of MVAs
for public viewing and posted on that occur because of drug-impaired Food and Drug Administration
https://www.regulations.gov. Submit driving is a public health priority.
Drugs that impair driving ability may [Docket No. FDA–2014–N–0920]
both copies to the Dockets Management
Staff. If you do not wish your name and also impair an individual’s ability to
Agency Information Collection
contact information to be made publicly judge the extent of his or her own
Activities; Submission for Office of
available, you can provide this impairment. This increases the need for
Management and Budget Review;
information on the cover sheet and not objective evaluation of the presence and
Comment Request; Health and Diet
in the body of your comments and you degree of driving impairment, with risk
Survey, as Used by the Food and Drug
must identify this information as mitigation strategies based on that
Administration
‘‘confidential.’’ Any information marked information. This guidance recommends
as ‘‘confidential’’ will not be disclosed a systematic effort to identify drugs for AGENCY: Food and Drug Administration,
except in accordance with 21 CFR 10.20 which evaluation of effects on driving HHS.
and other applicable disclosure law. For abilities may be needed and the types of ACTION: Notice.
studies that such an evaluation entails.
sradovich on DSK3GMQ082PROD with NOTICES
more information about FDA’s posting
of comments to public dockets, see 80 This guidance finalizes the draft SUMMARY: The Food and Drug
FR 56469, September 18, 2015, or access guidance issued on January 16, 2015, Administration (FDA or we) is
the information at: https://www.gpo.gov/ (80 FR 2432) of the same name. Changes announcing that a proposed collection
fdsys/pkg/FR-2015-09-18/pdf/2015- made to the guidance took into of information has been submitted to the
23389.pdf. consideration comments received. In Office of Management and Budget
Docket: For access to the docket to addition to editorial changes made (OMB) for review and clearance under
read background documents or the primarily for clarification, the guidance the Paperwork Reduction Act of 1995.
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![Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 52055
Agency identify and respond to Landsdown St., North Bethesda, MD recalled formula presents a risk to
emerging issues in a more timely 20852, 301–796–7726, PRAStaff@ human health, the recalling firm must
manner. fda.hhs.gov. also request that each establishment that
Dated: November 6, 2017. SUPPLEMENTARY INFORMATION: In sells the recalled formula post (at point
Anna K. Abram, compliance with 44 U.S.C. 3507, FDA of purchase) a notice of the recall and
has submitted the following proposed provide FDA with a copy of the notice.
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. collection of information to OMB for Section 107.240 requires the recalling
review and clearance. firm to conduct an infant formula recall
[FR Doc. 2017–24409 Filed 11–8–17; 8:45 am]
with the following elements: (1) Notify
BILLING CODE 4164–01–P Infant Formula Recall Regulations—21 the appropriate FDA district office of
CFR 107.230, 107.240, 107.250, 107.260, the recall by telephone within 24 hours,
and 107.280, OMB Control Number (2) submit a written report to that office
DEPARTMENT OF HEALTH AND 0910–0188—Extension
HUMAN SERVICES within 14 days, and (3) submit a written
Section 412(e) of the Federal Food, status report at least every 14 days until
Food and Drug Administration Drug, and Cosmetic Act (the FD&C Act) the recall is terminated. Before
(21 U.S.C. 350a(e)) provides that if the terminating a recall, the recalling firm is
[Docket No. FDA–2014–N–1027] manufacturer of an infant formula has required to submit a recommendation
knowledge that reasonably supports the for termination of the recall to the
Agency Information Collection
conclusion that an infant formula appropriate FDA district office and wait
Activities; Submission for Office of
processed by that manufacturer has left for FDA’s written concurrence
Management and Budget Review;
its control and may not provide the (§ 107.250). Where the recall strategy or
Comment Request; Infant Formula
nutrients required in section 412(i) of implementation is determined to be
Recall Regulations
the FD&C Act or is otherwise deficient, FDA may require the firm to
AGENCY: Food and Drug Administration, adulterated or misbranded, the change the extent of the recall, carry out
HHS. manufacturer must promptly notify the additional effectiveness checks, and
ACTION: Notice. Secretary of Health and Human Services issue additional notifications
(the Secretary). If the Secretary (§ 107.260). In addition, to facilitate
SUMMARY: The Food and Drug determines that the infant formula location of the product being recalled,
Administration (FDA or we) is presents a risk to human health, the the recalling firm is required to
announcing that a proposed collection manufacturer must immediately take all maintain distribution records for at least
of information has been submitted to the actions necessary to recall shipments of 1 year after the expiration of the shelf
Office of Management and Budget such infant formula from all wholesale life of the infant formula (§ 107.280).
(OMB) for review and clearance under and retail establishments, consistent The reporting and recordkeeping
the Paperwork Reduction Act of 1995. with recall regulations and guidelines requirements described previously are
DATES: Fax written comments on the issued by the Secretary. Section designed to enable FDA to monitor the
collection of information by December 412(f)(2) of the FD&C Act states that the effectiveness of infant formula recalls in
11, 2017. Secretary shall by regulation prescribe order to protect babies from infant
ADDRESSES: To ensure that comments on
the scope and extent of recalls of infant formula that may be unsafe because of
the information collection are received, formula necessary and appropriate for contamination, nutritional inadequacy,
OMB recommends that written the degree of risk to human health or is otherwise adulterated or
comments be faxed to the Office of presented by the formula subject to misbranded. FDA uses the information
recall. FDA’s infant formula recall collected under these regulations to
Information and Regulatory Affairs,
regulations in part 107 (21 CFR part
OMB, Attn: FDA Desk Officer, Fax: 202– help ensure that such products are
107) implement these statutory
395–7285, or emailed to oira_ quickly and efficiently removed from
provisions.
submission@omb.eop.gov. All Section 107.230 requires each the market.
comments should be identified with the recalling firm to conduct an infant In the Federal Register of June 15,
OMB control number 0910–0188. Also formula recall with the following 2017 (82 FR 27509), FDA published a
include the FDA docket number found elements: (1) Evaluate the hazard to 60-day notice requesting public
in brackets in the heading of this human health, (2) devise a written recall comment on the proposed collection of
document. strategy, (3) promptly notify each information. FDA received one
FOR FURTHER INFORMATION CONTACT: Ila affected direct account (customer) about comment that was unrelated to the
S. Mizrachi, Office of Operations, Food the recall, and (4) furnish the information collection.
and Drug Administration, Three White appropriate FDA district office with FDA estimates the burden of this
Flint North, 10A–12M, 11601 copies of these documents. If the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
sradovich on DSK3GMQ082PROD with NOTICES
107.230; Elements of an infant formula recall ..................... 2 1 2 4,450 8,900
107.240; Notification requirements ...................................... 2 1 2 1,482 2,964
107.250; Termination of an infant formula recall ................. 2 1 2 120 240
107.260; Revision of an infant formula recall 2 .................... 1 1 1 625 625
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Document Created: 2018-10-25 10:30:08
Document Modified: 2018-10-25 10:30:08
| 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 December 11, 2017. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 52053 |
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