80 FR 34670 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 116 (June 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34670-34672 | |
| FR Document | 2015-14888 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34670-34672] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14888] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0369] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget [[Page 34671]] (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 17, 2015. 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 0910-0212. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 [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. Under Federal Import Milk Act (FIMA) (21 U.S.C. 141-149), milk or cream may be imported into the United States only by the holder of a valid import milk permit (21 U.S.C. 141). Before such permit is issued: (1) All cows from which import milk or cream is produced must be physically examined and found healthy; (2) if the milk or cream is imported raw, all such cows must pass a tuberculin test; (3) the dairy farm and each plant in which the milk or cream is processed or handled must be inspected and found to meet certain sanitary requirements; (4) bacterial counts of the milk at the time of importation must not exceed specified limits; and (5) the temperature of the milk or cream at time of importation must not exceed 50[emsp14][deg]F (21 U.S.C. 142). Our regulations in part 1210 (21 CFR part 1210) implement the provisions of FIMA. Sections 1210.11 and 1210.14 require reports on the sanitary conditions of, respectively, dairy farms and plants producing milk and/or cream to be shipped to the United States. Section 1210.12 requires reports on the physical examination of herds, while Sec. 1210.13 requires the reporting of tuberculin testing of the herds. In addition, the regulations in part 1210 require that dairy farmers and plants maintain pasteurization records (Sec. 1210.15) and that each container of milk or cream imported into the United States bear a tag with the product type, permit number, and shipper's name and address (Sec. 1210.22). Section 1210.20 requires that an application for a permit to ship or transport milk or cream into the United States be made by the actual shipper. Section 1210.23 allows permits to be granted based on certificates from accredited officials. In the Federal Register of March 25, 2015 (80 FR 15794), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received in response to the notice. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Form No. Number of responses per Total annual Average burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.11............................ FDA 1996; Sanitary 2 200 400 1.5................... 600 Inspection of Dairy Farms. 1210.12............................ FDA 1995; Physical 1 1 1 0.5 (30 minutes)...... 0.5 Examination of Cows. 1210.13............................ FDA 1994; Tuberculin Test.. 1 1 1 0.5 (30 minutes)...... 0.5 1210.14............................ FDA 1997; Sanitary 2 1 2 2..................... 4 Inspections of Plants. 1210.20............................ FDA 1993; Application for 2 1 2 0.5 (30 minutes)...... 1 Permit. 1210.23............................ FDA 1815; Permits Granted 2 1 2 0.5 (30 minutes)...... 1 on Certificates. -------------------------------------------------------------------------------------------------------------------- Total.......................... ........................... .............. .............. .............. ...................... 607 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.15.................................................. 2 1 2 0.05 0.1 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated number of respondents and hours per response are based on our experience with the import milk permit program and the average number of import milk permit holders over the past three years. We estimate that two respondents will submit approximately 200 Form FDA 1996 reports annually, for a total of 600 responses. We estimate the reporting burden to be 1.5 hours per response, for a total burden of 607 hours. The Secretary of Health and Human Services has the discretion to allow Form FDA 1815, a duly certified statement signed by an accredited official of a foreign government, to be submitted in lieu of Forms FDA 1994 and 1995. To date, Form FDA 1815 has been submitted in lieu of these forms. Because we have not received any Forms FDA 1994 and 1995 in the last 3 years, the Agency estimates no more than one will be submitted annually. We estimate the reporting burden for each to be 0.5 hours per response for a total burden reporting burden of 0.5 hours each. We estimate that two respondents will submit one Form FDA 1997 report [[Page 34672]] annually, for a total of two responses. We estimate the reporting burden to be 2 hours per response, for a total burden of 4 hours. We estimate that two respondents will submit one Form FDA 1993 report annually, for a total of two responses. We estimate the reporting burden to be 0.5 hours per response, for a total burden of 1 hour. We estimate that two respondents will submit one Form FDA 1815 report annually, for a total of two responses. We estimate the reporting burden to be 0.5 hours per response, for a total burden of 1 hour. With regard to records maintenance, we estimate that approximately two recordkeepers will spend 0.05 hours annually maintaining the additional pasteurization records required by Sec. 1210.15, for a total of 0.10 hours annually. No burden has been estimated for the tagging requirement in Sec. 1210.22 because the information on the tag is either supplied by us (permit number) or is disclosed to third parties as a usual and customary part of the shipper's normal business activities (type of product, shipper's name and address). Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not subject to review by the Office of Management and Budget under the Paperwork Reduction Act. Under 5 CFR 1320.3(b)(2)), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of business activities. Dated: June 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14888 Filed 6-16-15; 8:45 am] BILLING CODE 4164-01-P
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43. Reeves, R. M., ‘‘Effect of Dietary Trans Heart Disease,’’ Journal of Internal
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration,
‘‘Trans Fatty Acids and their Effects on Evidence Review From the Lifestyle
HHS.
Lipoproteins in Humans,’’ Annual Work Group,’’ Bethesda, MD: HHS,
Review of Nutrition, 15:473–493, 1995. National Institutes of Health, 2013 ACTION: Notice.
45. Zock P. L. and R. P. Mensink, ‘‘Dietary (http://www.nhlbi.nih.gov/health-pro/
Trans-Fatty Acids and Serum guidelines/in-develop/cardiovascular- SUMMARY: The Food and Drug
Lipoproteins in Humans,’’ Current risk-reduction/lifestyle). Administration (FDA) is announcing
Opinion in Lipidology, 7:34–37, 1996. 59. Burlingame B., C. Nishida, R. Uauy, et al., that a proposed collection of
46. Oh, K., F. B. Hu, J. E. Manson, et al., ‘‘Fats and Fatty Acids in Human information has been submitted to the
‘‘Dietary Fat Intake and Risk of Coronary Nutrition: Introduction,’’ Annals of Office of Management and Budget
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![34672 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
annually, for a total of two responses. SUMMARY: The Food and Drug DATES: Fax written comments on the
We estimate the reporting burden to be Administration (FDA) is announcing collection of information by July 17,
2 hours per response, for a total burden that a collection of information entitled, 2015.
of 4 hours. We estimate that two ‘‘Food and Cosmetic Export Certificate ADDRESSES: To ensure that comments on
respondents will submit one Form FDA Applications Process’’ has been the information collection are received,
1993 report annually, for a total of two approved by the Office of Management OMB recommends that written
responses. We estimate the reporting and Budget (OMB) under the Paperwork comments be faxed to the Office of
burden to be 0.5 hours per response, for Reduction Act of 1995. Information and Regulatory Affairs,
a total burden of 1 hour. We estimate FOR FURTHER INFORMATION CONTACT: FDA OMB, Attn: FDA Desk Officer, FAX:
that two respondents will submit one PRA Staff, Office of Operations, Food 202–395–7285, or emailed to oira_
Form FDA 1815 report annually, for a and Drug Administration, 8455 submission@omb.eop.gov. All
total of two responses. We estimate the Colesville Rd., COLE–14526, Silver comments should be identified with the
reporting burden to be 0.5 hours per Spring, MD 20993–0002, OMB control number 0910-New and
response, for a total burden of 1 hour. PRAStaff@fda.hhs.gov. title ‘‘Impact of Ad Exposure Frequency
With regard to records maintenance, on Perception and Mental Processing of
we estimate that approximately two SUPPLEMENTARY INFORMATION: On April Risk and Benefit Information in Direct-
recordkeepers will spend 0.05 hours 23, 2015, the Agency submitted a To-Consumer Prescription Drug Ads.’’
annually maintaining the additional proposed collection of information Also include the FDA docket number
pasteurization records required by entitled, ‘‘Food and Cosmetic Export found in brackets in the heading of this
§ 1210.15, for a total of 0.10 hours Certificate Applications Process’’ to document.
annually. OMB for review and clearance under 44 FOR FURTHER INFORMATION CONTACT: FDA
No burden has been estimated for the U.S.C. 3507. An Agency may not PRA Staff, Office of Operations, Food
tagging requirement in § 1210.22 conduct or sponsor, and a person is not and Drug Administration, 8455
because the information on the tag is required to respond to, a collection of Colesville Rd., COLE–14526, Silver
either supplied by us (permit number) information unless it displays a Spring, MD 20993–0002, PRAStaff@
or is disclosed to third parties as a usual currently valid OMB control number. fda.hhs.gov.
and customary part of the shipper’s OMB has now approved the information
collection and has assigned OMB SUPPLEMENTARY INFORMATION: In
normal business activities (type of
control number 0910–0793. The compliance with 44 U.S.C. 3507, FDA
product, shipper’s name and address).
approval expires on May 31, 2018. A has submitted the following proposed
Under 5 CFR 1320.3(c)(2), the public
copy of the supporting statement for this collection of information to OMB for
disclosure of information originally
information collection is available on review and clearance.
supplied by the Federal Government to
the recipient for the purpose of the Internet at http://www.reginfo.gov/ Impact of Ad Exposure Frequency on
disclosure to the public is not subject to public/do/PRAMain. Perception and Mental Processing of
review by the Office of Management and Dated: June 11, 2015. Risk and Benefit Information in Direct-
Budget under the Paperwork Reduction Leslie Kux, to-Consumer Prescription Drug Ads;
Act. Under 5 CFR 1320.3(b)(2)), the Associate Commissioner for Policy.
OMB Control Number 0910–NEW
time, effort, and financial resources Section 1701(a)(4) of the Public
[FR Doc. 2015–14879 Filed 6–16–15; 8:45 am]
necessary to comply with a collection of Health Service Act (42 U.S.C.
BILLING CODE 4164–01–P
information are excluded from the 300u(a)(4)) authorizes the FDA to
burden estimate if the reporting, conduct research relating to health
recordkeeping, or disclosure activities DEPARTMENT OF HEALTH AND information. Section 1003(d)(2)(C) of the
needed to comply are usual and HUMAN SERVICES Federal Food, Drug, and Cosmetic Act
customary because they would occur in (the FD&C Act) (21 U.S.C. 393(b)(2)(c))
the normal course of business activities. Food and Drug Administration authorizes FDA to conduct research
Dated: June 11, 2015. relating to drugs and other FDA-
Leslie Kux, [Docket No. FDA–2014–N–1794] regulated products in carrying out the
Associate Commissioner for Policy. provisions of the FD&C Act.
[FR Doc. 2015–14888 Filed 6–16–15; 8:45 am] Agency Information Collection In a typical promotional campaign,
Activities; Submission for Office of consumers may be exposed to a direct-
BILLING CODE 4164–01–P
Management and Budget Review; to-consumer (DTC) prescription drug ad
Comment Request; Impact of Ad any number of times. Perceptual and
DEPARTMENT OF HEALTH AND Exposure Frequency on Perception cognitive effects of increased ad
HUMAN SERVICES and Mental Processing of Risk and exposure frequency have been studied
Benefit Information in Direct-to- extensively using non-drug ads. For
Food and Drug Administration Consumer Prescription Drug Ads instance, one study demonstrated that a
commercial message repeated twice
[Docket No. FDA–2014–N–2347] AGENCY: Food and Drug Administration, generates better recall than a message
HHS. broadcast only once (Ref. 1). Another
Agency Information Collection study demonstrated that increased ad
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice.
Activities; Announcement of Office of exposures improve product attitudes
Management and Budget Approval; SUMMARY: The Food and Drug and recall for product attributes,
Food and Cosmetic Export Certificate Administration (FDA) is announcing particularly when the substance of the
Applications Process that a proposed collection of repeat messages is varied (Ref. 2).
AGENCY: Food and Drug Administration, information has been submitted to the Generally, it has been argued that first
HHS. Office of Management and Budget exposure to an ad results in attention,
(OMB) for review and clearance under second exposure affects learning of the
ACTION: Notice.
the Paperwork Reduction Act of 1995. advertised message, and third and
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Document Created: 2015-12-15 14:23:10
Document Modified: 2015-12-15 14:23:10
| 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 | Fax written comments on the collection of information by July 17, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Road; COLE-14526, Silver Spring, MD 20993-0002 [email protected] | |
| FR Citation | 80 FR 34670 |
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