80 FR 15794 - Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 57 (March 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 57 (March 25, 2015)
| Page Range | 15794-15795 | |
| FR Document | 2015-06703 |
[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)] [Notices] [Pages 15794-15795] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06703] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0369] Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment in response to the notice. This notice invites comments on the reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA). DATES: Submit either electronic or written comments on the collection of information by May 26, 2015. ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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 Rd., COLE-14526, Silver Spring, MD 20993-0002, [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, we are publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of our functions, including whether the information will have practical utility; (2) the accuracy of our 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. Regulations Under the Federal Import Milk Act (FIMA)--21 CFR Part 1210 (OMB Control Number 0910-0212)--Extension Under 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[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. We estimate the burden of this collection of information as follows: [[Page 15795]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR Section Form No. Number of responses per Total annual burden per Total hours respondents respondent responses response -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.11................................ FDA 1996; Sanitary inspection 2 200 400 1.5 600 of dairy farms. 1210.12................................ FDA 1995; Physical examination 1 1 1 0.5 0.5 of cows. 1210.13................................ FDA 1994; Tuberculin test...... 1 1 1 0.5 0.5 1210.14................................ FDA 1997; Sanitary inspections 2 1 2 2.0 4.0 of plants. 1210.20................................ FDA 1993; Application for 2 1 2 0.5 1.0 permit. 1210.23................................ FDA 1815; Permits granted on 2 1 2 0.5 1.0 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 Average burden 21 CFR Section Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.15............................................................ 2 1 2 0.05 0.10 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 3 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 annually, for a total of two responses. We estimate the reporting burden to be 2.0 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: March 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-06703 Filed 3-24-15; 8:45 am] BILLING CODE 4164-01-P
![15794 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices
would constitute a clearly unwarranted information, and allow 60 days for information, including the validity of
invasion of personal privacy. public comment in response to the the methodology and assumptions used;
Name of Committee: Eunice Kennedy notice. This notice invites comments on (3) ways to enhance the quality, utility,
Shriver National Institute of Child Health the reporting and recordkeeping and clarity of the information to be
and Human Development Special Emphasis requirements of our regulations collected; and (4) ways to minimize the
Panel; Long-term health impacts of maternal implementing the Federal Import Milk burden of the collection of information
obesity and gestational diabetes on the Act (FIMA). on respondents, including through the
offspring: A trans-generational study. DATES: Submit either electronic or use of automated collection techniques,
Date: April 8, 2015. when appropriate, and other forms of
Time: 1:00 p.m. to 5:00 p.m.
written comments on the collection of
information by May 26, 2015. information technology.
Agenda: To review and evaluate contract
proposals. ADDRESSES: Submit electronic Regulations Under the Federal Import
Place: National Institutes of Health, 6100 comments on the collection of Milk Act (FIMA)—21 CFR Part 1210
Executive Boulevard, Rockville, MD 20852, information to http:// (OMB Control Number 0910–0212)—
(Telephone Conference Call). www.regulations.gov. Submit written Extension
Contact Person: Sathasiva B. Kandasamy, comments on the collection of
Ph.D., Scientific Review Officer, Scientific Under FIMA (21 U.S.C. 141–149),
Review Branch, Eunice Kennedy Shriver
information to the Division of Dockets
milk or cream may be imported into the
National Institute of Child Health and Management (HFA–305), Food and Drug
United States only by the holder of a
Human Development, NIH, 6100 Executive Administration, 5630 Fishers Lane, Rm.
valid import milk permit (21 U.S.C.
Boulevard, Room 5B01, Bethesda, MD 1061, Rockville, MD 20852. All
141). Before such permit is issued: (1)
20892–9304, (301) 435–6680, skandasa@ comments should be identified with the
All cows from which import milk or
mail.nih.gov. docket number found in brackets in the
cream is produced must be physically
(Catalogue of Federal Domestic Assistance heading of this document.
Program Nos. 93.864, Population Research; examined and found healthy; (2) if the
FOR FURTHER INFORMATION CONTACT: FDA milk or cream is imported raw, all such
93.865, Research for Mothers and Children; PRA Staff, Office of Operations, Food
93.929, Center for Medical Rehabilitation cows must pass a tuberculin test; (3) the
and Drug Administration, 8455 dairy farm and each plant in which the
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National Colesville Rd., COLE–14526, Silver milk or cream is processed or handled
Institutes of Health, HHS) Spring, MD 20993–0002, PRAStaff@ must be inspected and found to meet
fda.hhs.gov. certain sanitary requirements; (4)
Dated: March 19, 2015.
Michelle Trout, SUPPLEMENTARY INFORMATION: Under the bacterial counts of the milk at the time
Program Analyst, Office of Federal Advisory PRA (44 U.S.C. 3501–3520), Federal of importation must not exceed
Committee Policy. Agencies must obtain approval from the specified limits; and (5) the temperature
[FR Doc. 2015–06842 Filed 3–24–15; 8:45 am]
Office of Management and Budget of the milk or cream at time of
(OMB) for each collection of importation must not exceed 50°F (21
BILLING CODE 4140–01–P
information they conduct or sponsor. U.S.C. 142).
‘‘Collection of information’’ is defined Our regulations in part 1210 (21 CFR
DEPARTMENT OF HEALTH AND in 44 U.S.C. 3502(3) and 5 CFR part 1210), implement the provisions of
HUMAN SERVICES 1320.3(c) and includes Agency requests FIMA. Sections 1210.11 and 1210.14
or requirements that members of the require reports on the sanitary
Food and Drug Administration public submit reports, keep records, or conditions of, respectively, dairy farms
provide information to a third party. and plants producing milk and/or cream
[Docket No. FDA–2012–N–0369] Section 3506(c)(2)(A) of the PRA (44 to be shipped to the United States.
U.S.C. 3506(c)(2)(A)) requires Federal Section 1210.12 requires reports on the
Agency Information Collection
Agencies to provide a 60-day notice in physical examination of herds, while
Activities; Proposed Collection;
the Federal Register concerning each § 1210.13 requires the reporting of
Comment Request; Regulations Under
proposed collection of information, tuberculin testing of the herds. In
the Federal Import Milk Act
including each proposed extension of an addition, the regulations in part 1210
AGENCY: Food and Drug Administration, existing collection of information, require that dairy farmers and plants
HHS. before submitting the collection to OMB maintain pasteurization records
ACTION: Notice. for approval. To comply with this (§ 1210.15) and that each container of
requirement, we are publishing notice of milk or cream imported into the United
SUMMARY: The Food and Drug the proposed collection of information States bear a tag with the product type,
Administration (FDA or we) is set forth in this document. permit number, and shipper’s name and
announcing an opportunity for public With respect to the following address (§ 1210.22). Section 1210.20
comment on our proposed collection of collection of information, we invite requires that an application for a permit
certain information. Under the comments on these topics: (1) Whether to ship or transport milk or cream into
Paperwork Reduction Act of 1995 (the the proposed collection of information the United States be made by the actual
PRA), Federal Agencies must publish a is necessary for the proper performance shipper. Section 1210.23 allows permits
notice in the Federal Register of our functions, including whether the to be granted based on certificates from
concerning each proposed collection of information will have practical utility; accredited officials.
information, including each proposed (2) the accuracy of our estimate of the We estimate the burden of this
rljohnson on DSK3VPTVN1PROD with NOTICES
extension of an existing collection of burden of the proposed collection of collection of information as follows:
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![Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 15795
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR Section Form No. responses per burden per Total hours
respondents responses
respondent response
1210.11 ................ FDA 1996; Sanitary inspection of 2 200 400 1.5 600
dairy farms.
1210.12 ................ FDA 1995; Physical examination of 1 1 1 0.5 0.5
cows.
1210.13 ................ FDA 1994; Tuberculin test ................ 1 1 1 0.5 0.5
1210.14 ................ FDA 1997; Sanitary inspections of 2 1 2 2.0 4.0
plants.
1210.20 ................ FDA 1993; Application for permit ...... 2 1 2 0.5 1.0
1210.23 ................ FDA 1815; Permits granted on certifi- 2 1 2 0.5 1.0
cates.
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 Average
Number of Total annual
21 CFR Section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
1210.15 ................................................................................ 2 1 2 0.05 0.10
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of respondents Form FDA 1815 report annually, for a Dated: March 19, 2015.
and hours per response are based on our total of two responses. We estimate the Leslie Kux,
experience with the import milk permit reporting burden to be 0.5 hours per Associate Commissioner for Policy.
program and the average number of response, for a total burden of 1 hour. [FR Doc. 2015–06703 Filed 3–24–15; 8:45 am]
import milk permit holders over the With regard to records maintenance, BILLING CODE 4164–01–P
past 3 years. We estimate that two
we estimate that approximately two
respondents will submit approximately
recordkeepers will spend 0.05 hours
200 Form FDA 1996 reports annually, DEPARTMENT OF HEALTH AND
for a total of 600 responses. We estimate annually maintaining the additional
HUMAN SERVICES
the reporting burden to be 1.5 hours per pasteurization records required by
response, for a total burden of 607 § 1210.15, for a total of 0.10 hours Decision To Evaluate a Petition To
hours. annually. Designate a Class of Employees From
The Secretary of Health and Human No burden has been estimated for the the Hanford Site in Richland,
Services has the discretion to allow tagging requirement in § 1210.22 Washington, To Be Included in the
Form FDA 1815, a duly certified because the information on the tag is Special Exposure Cohort
statement signed by an accredited either supplied by us (permit number)
official of a foreign government, to be AGENCY: National Institute for
or is disclosed to third parties as a usual
submitted in lieu of Forms FDA 1994 Occupational Safety and Health
and customary part of the shipper’s (NIOSH), Centers for Disease Control
and 1995. To date, Form FDA 1815 has normal business activities (type of
been submitted in lieu of these forms. and Prevention, Department of Health
product, shipper’s name and address). and Human Services.
Because we have not received any Under 5 CFR 1320.3(c)(2), the public
Forms FDA 1994 and 1995 in the last 3 ACTION: Notice.
disclosure of information originally
years, the Agency estimates no more supplied by the Federal Government to
than one will be submitted annually. SUMMARY: NIOSH gives notice of a
the recipient for the purpose of decision to evaluate a petition to
We estimate the reporting burden for disclosure to the public is not subject to
each to be 0.5 hours per response for a designate a class of employees from the
review by the Office of Management and Hanford site in Richland, Washington,
total burden reporting burden of 0.5
Budget under the Paperwork Reduction to be included in the Special Exposure
hours each.
Act. Under 5 CFR 1320.3(b)(2)), the Cohort under the Energy Employees
We estimate that two respondents will
submit one Form FDA 1997 report time, effort, and financial resources Occupational Illness Compensation
annually, for a total of two responses. necessary to comply with a collection of Program Act of 2000.
We estimate the reporting burden to be information are excluded from the FOR FURTHER INFORMATION CONTACT:
2.0 hours per response, for a total burden estimate if the reporting, Stuart L. Hinnefeld, Director, Division
rljohnson on DSK3VPTVN1PROD with NOTICES
burden of 4 hours. We estimate that two recordkeeping, or disclosure activities of Compensation Analysis and Support,
respondents will submit one Form FDA needed to comply are usual and National Institute for Occupational
1993 report annually, for a total of two customary because they would occur in Safety and Health, 1090 Tusculum
responses. We estimate the reporting the normal course of business activities. Avenue, MS C–46, Cincinnati, OH
burden to be 0.5 hours per response, for 45226–1938, Telephone 877–222–7570.
a total burden of 1 hour. We estimate Information requests can also be
that two respondents will submit one submitted by email to DCAS@CDC.GOV.
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Document Created: 2018-02-21 09:49:04
Document Modified: 2018-02-21 09:49:04
| 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 May 26, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 15794 |
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