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, 52053-52055 [2017-24409]

Download as PDF Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES 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–D–2300 for ‘‘Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.’’ Received comments 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Naomi Lowy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4204, Silver Spring, MD 20993–0002, 301– 796–0692. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.’’ The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Driving is a complex activity involving a wide range of cognitive, perceptual, and motor activities that can be adversely affected by therapeutic drugs. Reducing the incidence of MVAs that occur because of drug-impaired driving is a public health priority. Drugs that impair driving ability may also impair an individual’s ability to judge the extent of his or her own impairment. This increases the need for objective evaluation of the presence and degree of driving impairment, with risk mitigation strategies based on that information. This guidance recommends a systematic effort to identify drugs for which evaluation of effects on driving abilities may be needed and the types of studies that such an evaluation entails. This guidance finalizes the draft guidance issued on January 16, 2015, (80 FR 2432) of the same name. Changes made to the guidance took into consideration comments received. In addition to editorial changes made primarily for clarification, the guidance PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 52053 provides multiple areas of clarification throughout the document. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on evaluating drug effects on the ability to operate a motor vehicle. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: November 3, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24367 Filed 11–8–17; 8:45 am] BILLING CODE 4164–01–P 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. 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. SUMMARY: E:\FR\FM\09NON1.SGM 09NON1 52054 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices 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 oira_ submission@omb.eop.gov. 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. DATES: 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, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 respondents Activity Number of responses per respondent Total annual responses Cognitive interview screener ........................................... 100 1 100 Cognitive interview .......................................................... Pretest screener .............................................................. Pretest ............................................................................. Survey screener .............................................................. Survey ............................................................................. 18 2,000 200 40,000 4,000 1 1 1 1 1 Total ......................................................................... ........................ ........................ sradovich on DSK3GMQ082PROD with NOTICES 1 There Average burden per response Total hours 18 2,000 200 40,000 4,000 .08 ...................... (5 minutes) ......... 1 ......................... .033 (2 minutes) .25 (15 minutes) .033 (2 minutes) .25 (15 minutes) 8 18 66 50 1,320 1,000 ........................ ............................ 2,462 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 VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 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 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 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 E:\FR\FM\09NON1.SGM 09NON1 52055 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1027] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0188. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 FOR FURTHER INFORMATION CONTACT: Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280, OMB Control Number 0910–0188—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant formula has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer has left its control and may not provide the nutrients required in section 412(i) of the FD&C Act or is otherwise adulterated or misbranded, the manufacturer must promptly notify the Secretary of Health and Human Services (the Secretary). If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. Section 412(f)(2) of the FD&C Act states that the Secretary shall by regulation prescribe the scope and extent of recalls of infant formula necessary and appropriate for the degree of risk to human health presented by the formula subject to recall. FDA’s infant formula recall regulations in part 107 (21 CFR part 107) implement these statutory provisions. Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements: (1) Evaluate the hazard to human health, (2) devise a written recall strategy, (3) promptly notify each affected direct account (customer) about the recall, and (4) furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements: (1) Notify the appropriate FDA district office of the recall by telephone within 24 hours, (2) submit a written report to that office within 14 days, and (3) submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for FDA’s written concurrence (§ 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications (§ 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula (§ 107.280). The reporting and recordkeeping requirements described previously are designed to enable FDA to monitor the effectiveness of infant formula recalls in order to protect babies from infant formula that may be unsafe because of contamination, nutritional inadequacy, or is otherwise adulterated or misbranded. FDA uses the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. In the Federal Register of June 15, 2017 (82 FR 27509), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment that was unrelated to the information collection. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 sradovich on DSK3GMQ082PROD with NOTICES 107.230; 107.240; 107.250; 107.260; Elements of an infant formula recall ..................... Notification requirements ...................................... Termination of an infant formula recall ................. Revision of an infant formula recall 2 .................... VerDate Sep<11>2014 17:32 Nov 08, 2017 Jkt 244001 Number of responses per respondent Number of respondents 21 CFR section/activity PO 00000 Frm 00018 2 2 2 1 Fmt 4703 Sfmt 4703 Average burden per response Total annual responses 1 1 1 1 E:\FR\FM\09NON1.SGM 2 2 2 1 09NON1 4,450 1,482 120 625 Total hours 8,900 2,964 240 625

Agencies

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52053-52055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 oira_submission@omb.eop.gov. 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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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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