83 FR 13288 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 60 (March 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 60 (March 28, 2018)
| Page Range | 13288-13290 | |
| FR Document | 2018-06154 |
[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)] [Notices] [Pages 13288-13290] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06154] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6397] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget [[Page 13289]] (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 27, 2018. 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 0910-0782. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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. Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments--21 CFR Part 101 OMB Control Numbers 0910-0782 and 0910-0783--Consolidation This information collection supports FDA regulations under 21 CFR 101. As published in the Federal Register of December 1, 2014 (79 FR 71156 and 71259), regulations at 21 CFR 101.8 and 101.11 were revised to provide for the nutritional analysis of certain foods and for the disclosure of that information on applicable products purchased by consumers. The regulations also provide for the registration of certain individuals who become subject to the requirements, for which we developed Form FDA 3757 entitled, ``DHHS/FDA Menu and Vending Machine Labeling Voluntary Registration,'' to assist respondents in this regard. To keep the registration active, respondents must renew the registration every other year within 60 days prior to the expiration of the establishment's current registration with FDA, or it will automatically expire. In the Federal Register of December 12, 2017 (82 FR 58425), we published a 60-day notice requesting public comment on the proposed information collection. A number of comments were received in response to the notice. The comments were generally supportive of the information collection, but included concerns about the potential effect the ongoing or delayed rulemaking to establish specific packaging requirements (e.g., font-size of labeling, compliance dates) might have on the associated third-party disclosure burden. Other comments questioned whether FDA needed all data currently being sought by the applicable regulations and suggested the registration schedule be relaxed, especially given the small number of respondents. We are very appreciative of these comments. At the same time, upon our own review of the information collection, we are seeking to consolidate the burden currently approved under OMB control number 0910-0783 with 0910-0782 because it is intended to account for similar collection activities and is supported by the same collection instrument (Form FDA 3757) identified above. Also, as neither the public comments we received nor our own evaluation suggested we revise our original figures, we are retaining the currently approved estimated burden for the information collection, which is as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- 21 CFR 101.8 and 101.11 Number of Average burden registration using form FDA Number of responses per Total annual per response (in Total hours 3757 respondents respondent responses hours) ---------------------------------------------------------------------------------------------------------------- Sec. 101.8(d); initial 13 1 13 2............... 26 registration. Sec. 101.8(d); registration 19 1 19 .5 (30 minutes). 9.5 renewal. Sec. 101.11(d) initial 3,559 1 3,559 2............... 7,118 registration. Sec. 101.11(d) registration 5,340 1 5,340 .5 (30 minutes). 2,670 reviewal. --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 9,823.5 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR part 101 Number of frequency per Total annual Hours per record Total hours recordkeepers recordkeeper records ---------------------------------------------------------------------------------------------------------------- Initial Burden (Annualized over 3 years) ---------------------------------------------------------------------------------------------------------------- Sec. 101.8(c)(2)(i)(A); 69,017 1 69,017 .25 (15 minutes) 17,254 Initial nutrition analysis. ---------------------------------------------------------------------------------------------------------------- Annual Burden ---------------------------------------------------------------------------------------------------------------- Sec. 101.8(c)(2)(i)(A); 30,059 1 30,059 .25 (15 minutes) 7,515 Recurring nutrition analysis. --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 24,769 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 13290]] Table 3--Estimated Annual Third-Party Disclosure Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR part 101 Number of disclosures Total annual per disclosure Total hours respondents per respondent disclosures (in hours) ---------------------------------------------------------------------------------------------------------------- Sec. 101.8(c)(2)(i); calorie 282 11 3,102 1............... 3,102 analysis. Sec. 101.8(c)(2)(ii); 3,279 2,122 6,958,038 .21 (12.5 1,461,188 calorie declaration signage. minutes). Sec. 101.8(e)(1); vending 3,279 125 409,875 .025 (1.5 10,247 operator contact information. minutes). --------------------------------------------------------------------------------- Total..................... .............. .............. .............. ................ 1,474,537 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with the information collection. These figures are based on our analyses in support of the underlying rulemaking cited above and there is no burden increase since the previous OMB approvals. Because these are newly established information collection provisions, we continue to evaluate the collection burden and solicit public comment, noting that the effective dates and/or compliance dates for certain provisions have not yet been realized. Dated: March 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06154 Filed 3-27-18; 8:45 am] BILLING CODE 4164-01-P
![13288 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
difference could lead to liability ‘‘essentially a copy’’ of the regarding what such documentation
concerns (e.g., for a pharmacy manager commercially-available product. The may contain, but we did provide
who makes representations to an outsourcing facility may decide in this appropriate examples. Under the
outsourcing facility about how a drug scenario to not compound the drug. guidance, both a prescribing practitioner
will be used) and scope of practice Issue Three: At least one commenter and a person able to make a
concerns (if a doctor concludes he or recommended that the guidance representation for the practitioner, such
she should not be bound by the requires practitioners to provide as, potentially, a hospital pharmacy
representations). additional details regarding the patient manager, would be able to produce a
FDA Response to Issue Two: For population in need of a compounded statement of clinical difference.
certain drugs, one of the conditions to drug as part of the prescriber Issue Four: At least one commenter
qualify for exemptions under section determination of clinical difference, and asked about the acceptability of specific
503B is that there is a change that that both a hospital and practitioner means of applying a determination
produces for an individual patient a should produce statements of clinical statement to a product order.
clinical difference, as determined by the difference. FDA Response to Issue Four: FDA
prescribing practitioner, between the FDA Response to Issue Three: FDA’s does not believe a particular format is
compounded drug and the comparable draft guidance states that when an needed for a prescriber determination of
approved drug. If a pharmacy manager outsourcing facility intends to rely on a clinical difference, provided that the
does not wish to document on the order prescriber determination to establish determination clearly identifies the
that such a drug will only be that a compounded drug is not relevant change made to the
administered after an appropriate essentially a copy of an approved drug, compounded product and the clinical
prescriber determination, the manager the outsourcing facility should ensure difference that the change will produce
could ask the prescriber to provide that the determination is documented for patient(s), as determined by the
documentation. If a prescriber, or on the prescription or order for the prescriber.
person able to make a representation for compounded drug. This means the As none of the comments suggested
a prescriber, refuses to confirm that a determination is referenced in the that we revise our estimated burden for
compounded drug produces a clinical statute at section 503B(d)(2), which FDA the information collection, we have
difference for a patient, the cannot change through guidance. FDA retained our original estimate as
compounded drug may be considered cannot give exhaustive guidance follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of reporting recommendations in guidance burden per Total hours
respondents per disclosures disclosure
respondent
Consultation between the outsourcing facility and 40 100 4,000 0.05 (3 minutes) ..... 200
prescriber or health care facility, and the notation
on the prescription or order documenting the pre-
scriber’s determination of clinical difference.
Checking FDA’s drug shortage list and documenting 30 100 3,000 0.03 (2 minutes) ..... 100
on the prescription that the drug is in shortage.
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that annually a total of (‘‘number of respondents’’ in table 1, DEPARTMENT OF HEALTH AND
approximately 40 outsourcing facilities line 2) will document this information HUMAN SERVICES
(‘‘number of respondents’’ in table 1, on approximately 3,000 prescriptions or
line 1) will consult a prescriber to orders for compounded drugs (‘‘total Food and Drug Administration
determine whether he or she has made annual disclosures’’ in table 1, line 2). [Docket No. FDA–2017–N–6397]
a determination that the compounded We estimate that checking FDA’s drug
drug has a change that produces a shortage list and documenting this Agency Information Collection
clinical difference for an individual information will take approximately 2 Activities; Submission for Office of
patient as compared to the comparable minutes per prescription or order. Management and Budget Review;
approved drug and that outsourcing Comment Request; Food Labeling;
Dated: March 22, 2018.
facilities will document this Calorie Labeling of Articles of Food in
determination on approximately 4,000 Leslie Kux, Vending Machines and Nutrition
prescriptions or orders for compounded Associate Commissioner for Policy. Labeling of Standard Menu Items in
drugs (‘‘total annual disclosures’’ in [FR Doc. 2018–06169 Filed 3–27–18; 8:45 am] Restaurants and Similar Retail Food
table 1, line 1). We estimate that the BILLING CODE 4164–01–P Establishments
consultation between the outsourcing
AGENCY: Food and Drug Administration,
facility and the prescriber or health care
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
facility contact adding a notation to
each prescription or order that does not ACTION: Notice.
already document this determination SUMMARY: The Food and Drug
will take approximately 3 minutes per Administration (FDA, Agency, or we) is
prescription or order. announcing that a proposed collection
We estimate that a total of of information has been submitted to the
approximately 30 outsourcing facilities Office of Management and Budget
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![13290 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
Number of disclosures Total annual Average burden per disclosure
21 CFR part 101 Total hours
respondents per disclosures (in hours)
respondent
§ 101.8(c)(2)(i); calorie analysis ........ 282 11 3,102 1 ....................................................... 3,102
§ 101.8(c)(2)(ii); calorie declaration 3,279 2,122 6,958,038 .21 (12.5 minutes) ............................ 1,461,188
signage.
§ 101.8(e)(1); vending operator con- 3,279 125 409,875 .025 (1.5 minutes) ............................ 10,247
tact information.
Total ........................................... ........................ ........................ ........................ ........................................................... 1,474,537
1 There are no capital costs or operating and maintenance costs associated with the information collection.
These figures are based on our information on the proposed projects or establish policy, to direct program
analyses in support of the underlying to obtain a copy of the information activities, and to better allocate
rulemaking cited above and there is no collection plans, call the SAMHSA resources.
burden increase since the previous OMB Reports Clearance Officer on (240) 276– While NSDUH must be updated
approvals. Because these are newly 1243. periodically to reflect changing
established information collection Comments are invited on: (a) Whether substance use and mental health issues,
provisions, we continue to evaluate the the proposed collections of information and to continue producing current data,
collection burden and solicit public are necessary for the proper only the following minor changes are
comment, noting that the effective dates performance of the functions of the planned for the 2019 NSDUH: (1)
and/or compliance dates for certain agency, including whether the Adding a brief series of questions on
provisions have not yet been realized. information shall have practical utility; medication-assisted treatment (MAT) for
(b) the accuracy of the agency’s estimate opioids and alcohol; and, (2) including
Dated: March 22, 2018.
of the burden of the proposed collection other minor wording changes to
Leslie Kux,
of information; (c) ways to enhance the improve the flow of the interview, to
Associate Commissioner for Policy. quality, utility, and clarity of the
[FR Doc. 2018–06154 Filed 3–27–18; 8:45 am]
increase respondent comprehension, or
information to be collected; and, (d) to be consistent with text in other
BILLING CODE 4164–01–P ways to minimize the burden of the questions.
collection of information on
respondents, including through the use The series of MAT questions seeks to
DEPARTMENT OF HEALTH AND of automated collection techniques or identify medications prescribed by
HUMAN SERVICES other forms of information technology. health professionals to help reduce or
stop the use of opioids and alcohol.
Substance Abuse and Mental Health Proposed Project: 2019 National Survey Including these questions in NSDUH
Services Administration on Drug Use and Health OMB No. will allow SAMHSA to provide the first
0930–0110—Revision known national-level estimates on the
Agency Information Collection use of MAT for opioid use disorder and
The National Survey on Drug Use and
Activities: Proposed Collection; alcohol use disorder.
Health (NSDUH) is a survey of the U.S.
Comment Request
civilian, non-institutionalized As with all NSDUH surveys
In compliance with section population aged 12 years old or older. conducted since 1999, including those
3506(c)(2)(A) of the Paperwork The data are used to determine the prior to 2002 when the NSDUH was
Reduction Act of 1995 concerning prevalence of use of tobacco products, referred to as the National Household
opportunity for public comment on alcohol, illicit substances, and illicit use Survey on Drug Abuse, the sample size
proposed collections of information, the of prescription drugs. The results are of the survey for 2019 will be sufficient
Substance Abuse and Mental Health used by SAMHSA, the Office of to permit prevalence estimates for each
Services Administration (SAMHSA) National Drug Control Policy (ONDCP), of the 50 states and the District of
will publish periodic summaries of federal government agencies, and other Columbia. The total annual burden
proposed projects. To request more organizations and researchers to estimate is shown below in Table 1.
TABLE 1—ANNUALIZED ESTIMATED BURDEN FOR 2019 NSDUH
Responses
Number of Total number Hours per Total burden
Instrument per
respondents of responses response hours
respondent
Household Screening ........................................................... 137,231 1 137,231 0.083 11,390
Interview ............................................................................... 67,507 1 67,507 1.000 67,507
Screening Verification .......................................................... 4,116 1 4,116 0.067 276
daltland on DSKBBV9HB2PROD with NOTICES
Interview Verification ............................................................ 10,126 1 10,126 0.067 678
Total .............................................................................. 137,231 ........................ 218,980 ........................ 79,851
Send comments to Summer King, Room 15E57B, 5600 Fishers Lane, Rockville, MD 20857 OR email a copy
SAMHSA Reports Clearance Officer, to summer.king@samhsa.hhs.gov.
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Document Created: 2018-11-01 08:56:13
Document Modified: 2018-11-01 08:56:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by April 27, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 13288 |
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