83 FR 31155 - 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 83, Issue 128 (July 3, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 128 (July 3, 2018)
| Page Range | 31155-31156 | |
| FR Document | 2018-14266 |
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)] [Notices] [Pages 31155-31156] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14266] ----------------------------------------------------------------------- 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 (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). DATES: Fax written comments on the collection of information by August 2, 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 [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: 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]. 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. 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 [[Page 31156]] 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. In the Federal Register of April 2, 2018 (83 FR 13992), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section Form FDA No. Number of responses per Total annual Average burden per response Total respondents respondent responses hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.11....................... 1996/Sanitary inspection of 2 200 400 1.5............................... 600 dairy farms. 1210.12....................... 1995/Physical examination 1 1 1 0.5 (30 minutes).................. 0.5 of cows. 1210.13....................... 1994/Tuberculin test....... 1 1 1 0.5 (30 minutes).................. 0.5 1210.14....................... 1997/Sanitary inspections 2 1 2 2................................. 4 of plants. 1210.20....................... 1993/Application for permit 2 1 2 0.5 (30 minutes).................. 1 1210.23....................... 1815/Permits granted on 2 1 2 0.5 (30 minutes).................. 1 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 records per Total annual Average burden Total hours recordkeepers recordkeeper records per recordkeeping ---------------------------------------------------------------------------------------------------------------- 1210.15............. 2 1 2 0.05 (3 minutes). 0.10 (6 minutes). ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Upon review of the information collection, we have retained the currently approved estimated burden. 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. Assuming two respondents will submit approximately 200 Form FDA 1996 reports annually for a total of 600 responses, and that each response requires 1.5 hours, we estimate the total burden is 600 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 or 1995 in the last 3 years, we assume no more than one will be submitted annually. We also assume each submission requires 0.5 hour for a total of 0.5 burden hour annually. 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 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 hour 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 hour per response, for a total burden of 1 hour. With regard to records maintenance, we estimate that approximately two recordkeepers will spend 0.05 hour annually maintaining the additional pasteurization records required by Sec. 1210.15, for a total of 0.10 hour 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 OMB under the PRA. 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 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14266 Filed 7-2-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices 31155
in the body of your comments and you available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
must identify the information as AdvisoryCommittees/Calendar/ HUMAN SERVICES
‘‘confidential.’’ Any information marked default.htm. Scroll down to the
as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting Food and Drug Administration
except in accordance with 21 CFR 10.20 link. [Docket No. FDA–2012–N–0369]
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, Agency Information Collection
of comments to public dockets, see 80 orally or in writing, on issues pending Activities; Submission for Office of
FR 56469, September 18, 2015, or access before the committee. All electronic and Management and Budget Review;
the information at: https://www.gpo.gov/ written submissions submitted to the Comment Request; Regulations Under
fdsys/pkg/FR-2015-09-18/pdf/2015- Dockets Management Staff (see the the Federal Import Milk Act
23389.pdf. ADDRESSES section) on or before July 24,
Docket: For access to the docket to 2018, will be provided to the committee. AGENCY: Food and Drug Administration,
read background documents or the Oral presentations from the public will HHS.
electronic and written/paper comments be scheduled between approximately ACTION: Notice.
received, go to https:// 1:30 p.m. and 2:30 p.m. Those
individuals interested in making formal SUMMARY: The Food and Drug
www.regulations.gov and insert the
oral presentations should notify the Administration (FDA) is announcing
docket number, found in brackets in the
contact person and submit a brief that a proposed collection of
heading of this document, into the
statement of the general nature of the information has been submitted to the
‘‘Search’’ box and follow the prompts
evidence or arguments they wish to Office of Management and Budget
and/or go to the Dockets Management
present, the names and addresses of (OMB) for review and clearance under
Staff, 5630 Fishers Lane, Rm. 1061,
proposed participants, and an the Paperwork Reduction Act of 1995
Rockville, MD 20852.
indication of the approximate time (PRA).
FOR FURTHER INFORMATION CONTACT:
Lauren D. Tesh, Center for Drug requested to make their presentation on DATES: Fax written comments on the
Evaluation and Research, Food and or before July 16, 2018. Time allotted for collection of information by August 2,
Drug Administration, 10903 New each presentation may be limited. If the 2018.
Hampshire Ave., Bldg. 31, Rm. 2417, number of registrants requesting to ADDRESSES: To ensure that comments on
Silver Spring, MD 20993–0002, 301– speak is greater than can be reasonably the information collection are received,
796–9001, Fax: 301–847–8533, email: accommodated during the scheduled OMB recommends that written
AMDAC@fda.hhs.gov, or FDA Advisory open public hearing session, FDA may comments be faxed to the Office of
Committee Information Line, 1–800– conduct a lottery to determine the Information and Regulatory Affairs,
741–8138 (301–443–0572 in the speakers for the scheduled open public OMB, Attn: FDA Desk Officer, Fax: 202–
Washington, DC area). A notice in the hearing session. The contact person will 395–7285, or emailed to oira_
Federal Register about last minute notify interested persons regarding their submission@omb.eop.gov. All
modifications that impact a previously request to speak by July 17, 2018. comments should be identified with the
announced advisory committee meeting Persons attending FDA’s advisory OMB control number 0910–0212. Also
cannot always be published quickly committee meetings are advised that include the FDA docket number found
enough to provide timely notice. FDA is not responsible for providing in brackets in the heading of this
Therefore, you should always check the access to electrical outlets. document.
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the
Office of Media Affairs at fdaoma@ FOR FURTHER INFORMATION CONTACT:
AdvisoryCommittees/default.htm and Domini Bean, Office of Operations,
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the Food and Drug Administration, Three
committee meeting link, or call the White Flint North, 10A–12M, 11601
advisory committee information line to public at its advisory committee
meetings and will make every effort to Landsdown St., North Bethesda, MD
learn about possible modifications 20852, 301–796–5733, PRAStaff@
before coming to the meeting. accommodate persons with disabilities.
If you require accommodations due to a fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
disability, please contact Lauren Tesh SUPPLEMENTARY INFORMATION: In
Agenda: The committee will discuss (see FOR FURTHER INFORMATION CONTACT)
new drug application (NDA) 207356, compliance with 44 U.S.C. 3507, FDA
at least 7 days in advance of the has submitted the following proposed
amikacin liposome inhalation meeting.
suspension, sponsored by Insmed, Inc., collection of information to OMB for
FDA is committed to the orderly review and clearance.
for the proposed indication of treatment conduct of its advisory committee
of nontuberculous mycobacterial lung meetings. Please visit our website at Regulations Under the Federal Import
disease caused by Mycobacterium https://www.fda.gov/Advisory Milk Act (FIMA)—21 CFR Part 1210
avium complex in adults as part of a Committees/AboutAdvisoryCommittees/
combination antibacterial drug regimen. OMB Control Number 0910–0212—
ucm111462.htm for procedures on Extension
FDA intends to make background public conduct during advisory
material available to the public no later committee meetings. Under FIMA (21 U.S.C. 141–149),
than 2 business days before the meeting. Notice of this meeting is given under milk or cream may be imported into the
If FDA is unable to post the background United States only by the holder of a
sradovich on DSK3GMQ082PROD with NOTICES
the Federal Advisory Committee Act
material on its website prior to the (5 U.S.C. app. 2). valid import milk permit (21 U.S.C.
meeting, the background material will 141). Before such permit is issued: (1)
be made publicly available at the Dated: June 27, 2018. All cows from which import milk or
location of the advisory committee Leslie Kux, cream is produced must be physically
meeting, and the background material Associate Commissioner for Policy. examined and found healthy; (2) if the
will be posted on FDA’s website after [FR Doc. 2018–14240 Filed 7–2–18; 8:45 am] milk or cream is imported raw, all such
the meeting. Background material is BILLING CODE 4164–01–P cows must pass a tuberculin test; (3) the
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![31156 Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
dairy farm and each plant in which the and plants producing milk and/or cream requires that an application for a permit
milk or cream is processed or handled to be shipped to the United States. to ship or transport milk or cream into
must be inspected and found to meet Section 1210.12 requires reports on the the United States be made by the actual
certain sanitary requirements; (4) physical examination of herds, while shipper. Section 1210.23 allows permits
bacterial counts of the milk at the time § 1210.13 requires the reporting of to be granted based on certificates from
of importation must not exceed tuberculin testing of the herds. In accredited officials.
specified limits; and (5) the temperature addition, the regulations in part 1210 In the Federal Register of April 2,
of the milk or cream at time of require that dairy farmers and plants 2018 (83 FR 13992), FDA published a
importation must not exceed 50 °F (21 maintain pasteurization records 60-day notice requesting public
U.S.C. 142).
(§ 1210.15) and that each container of comment on the proposed collection of
Our regulations in part 1210 (21 CFR
part 1210), implement the provisions of milk or cream imported into the United information. No comments were
FIMA. Sections 1210.11 and 1210.14 States bear a tag with the product type, received.
require reports on the sanitary permit number, and shipper’s name and We estimate the burden of this
conditions of, respectively, dairy farms address (§ 1210.22). Section 1210.20 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
21 CFR Number of Total
Form FDA No. responses per annual burden per
Section respondents hours
respondent responses response
1210.11 .......... 1996/Sanitary inspection of dairy farms ...... 2 200 400 1.5 ......................... 600
1210.12 .......... 1995/Physical examination of cows ............. 1 1 1 0.5 (30 minutes) .... 0.5
1210.13 .......... 1994/Tuberculin test .................................... 1 1 1 0.5 (30 minutes) .... 0.5
1210.14 .......... 1997/Sanitary inspections of plants ............. 2 1 2 2 ............................ 4
1210.20 .......... 1993/Application for permit .......................... 2 1 2 0.5 (30 minutes) .... 1
1210.23 .......... 1815/Permits granted on certificates ........... 2 1 2 0.5 (30 minutes) .... 1
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
21 CFR Number of Total annual
records per burden per Total hours
Section recordkeepers records
recordkeeper recordkeeping
1210.15 .......... 2 1 2 0.05 (3 minutes) ............................................................. 0.10 (6 minutes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Upon review of the information We estimate that two respondents will either supplied by us (permit number)
collection, we have retained the submit one Form FDA 1997 report or is disclosed to third parties as a usual
currently approved estimated burden. annually, for a total of two responses. and customary part of the shipper’s
The estimated number of respondents We estimate the reporting burden to be normal business activities (type of
and hours per response are based on our 2 hours per response, for a total burden product, shipper’s name and address).
experience with the import milk permit of 4 hours. Under 5 CFR 1320.3(c)(2), the public
program and the average number of We estimate that two respondents will disclosure of information originally
import milk permit holders over the submit one Form FDA 1993 report supplied by the Federal Government to
past 3 years. Assuming two respondents annually, for a total of two responses. the recipient for the purpose of
will submit approximately 200 Form We estimate the reporting burden to be disclosure to the public is not subject to
FDA 1996 reports annually for a total of 0.5 hour per response, for a total burden review by OMB under the PRA. Under
600 responses, and that each response of 1 hour. 5 CFR 1320.3(b)(2), the time, effort, and
requires 1.5 hours, we estimate the total We estimate that two respondents will financial resources necessary to comply
burden is 600 hours. submit one Form FDA 1815 report with a collection of information are
The Secretary of Health and Human annually, for a total of two responses.
excluded from the burden estimate if
Services has the discretion to allow We estimate the reporting burden to be
the reporting, recordkeeping, or
Form FDA 1815, a duly certified 0.5 hour per response, for a total burden
disclosure activities needed to comply
statement signed by an accredited of 1 hour.
are usual and customary because they
official of a foreign government, to be With regard to records maintenance,
we estimate that approximately two would occur in the normal course of
submitted in lieu of Forms FDA 1994
and 1995. To date, Form FDA 1815 has recordkeepers will spend 0.05 hour business activities.
sradovich on DSK3GMQ082PROD with NOTICES
been submitted in lieu of these forms. annually maintaining the additional Dated: June 28, 2018.
Because we have not received any pasteurization records required by Leslie Kux,
Forms FDA 1994 or 1995 in the last 3 § 1210.15, for a total of 0.10 hour Associate Commissioner for Policy.
years, we assume no more than one will annually.
[FR Doc. 2018–14266 Filed 7–2–18; 8:45 am]
be submitted annually. We also assume No burden has been estimated for the
BILLING CODE 4164–01–P
each submission requires 0.5 hour for a tagging requirement in § 1210.22
total of 0.5 burden hour annually. because the information on the tag is
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Document Created: 2018-07-02 23:55:26
Document Modified: 2018-07-02 23:55:26
| 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 August 2, 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 31155 |
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