83 FR 13992 - 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 83, Issue 63 (April 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 63 (April 2, 2018)
| Page Range | 13992-13994 | |
| FR Document | 2018-06595 |
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)] [Notices] [Pages 13992-13994] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06595] ----------------------------------------------------------------------- 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 Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits 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 June 1, 2018. ADDRESSES: You may submit comments as follows: Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 1, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a 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-2012-N-0369 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations under the Federal Import Milk Act.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 [[Page 13993]] 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the 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. 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: 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, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's 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: 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 hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.11.................... 1996/Farm Inspection Report 2 200 400 1.5........................... 600 1210.12.................... 1995/Report of Physical 1 1 1 .5 (30 minutes)............... .5 Examination of Cows. 1210.13.................... 1994/Report of Tuberculin 1 1 1 .5 (30 minutes)............... .5 Tests of Cattle. 1210.14.................... 1997/Score Card for 2 1 2 2............................. 4 Sanitation Inspections of Milk Plants. 1210.20.................... 1993/Application for Permit 2 1 2 .5 (30 minutes)............... 1 to Ship or Transport Milk and/or Cream into US. 1210.23.................... 1815/Certificate/ 2 1 2 .5 (30 minutes)............... 1 Transmittal for an Application. ----------------------------------------------------------------------------------------------- Total.................. ........................... .............. .............. .............. .............................. 607 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 13994]] Table 2--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- 1210.15................................ 2 1 2 .05 (3 minutes)................ .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 2.0 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 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 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 27, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06595 Filed 3-30-18; 8:45 am] BILLING CODE 4164-01-P
![13992 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
Evaluation and Research and Center for Dated: March 22, 2018. comment will be made public, you are
Biologics and Research committed to Leslie Kux, solely responsible for ensuring that your
further our efforts to enhance benefit- Associate Commissioner for Policy. comment does not include any
risk assessment and communication in [FR Doc. 2018–06531 Filed 3–30–18; 8:45 am] confidential information that you or a
the human drug review process in FY BILLING CODE 4164–01–P third party may not wish to be posted,
2013–2017. Enhancing and such as medical information, your or
communicating benefit-risk assessment anyone else’s Social Security number, or
continues to be an Agency priority in DEPARTMENT OF HEALTH AND confidential business information, such
PDUFA VI. The draft plan describes the HUMAN SERVICES as a manufacturing process. Please note
that if you include your name, contact
progress made on PDUFA V in benefit-
Food and Drug Administration information, or other information that
risk assessment. This progress includes
[Docket No. FDA–2012–N–0369] identifies you in the body of your
revision of FDA’s review/decision comments, that information will be
templates and manuals to incorporate posted on https://www.regulations.gov.
Agency Information Collection
FDA’s approach to benefit-risk • If you want to submit a comment
Activities; Proposed Collection;
assessment, training review and with confidential information that you
Comment Request; Regulations Under
management of staff on the revised the Federal Import Milk Act do not wish to be made available to the
templates and manuals, developing an public, submit the comment as a
evaluation plan to ascertain the impact AGENCY: Food and Drug Administration, written/paper submission and in the
of FDA’s implementation of the Benefit- HHS. manner detailed (see ‘‘Written/Paper
Risk Framework in drug review, holding ACTION: Notice. Submissions’’ and ‘‘Instructions’’).
two public workshops on benefit-risk Written/Paper Submissions
SUMMARY: The Food and Drug
considerations from the regulator’s Administration (FDA or Agency) is
perspective, and advancing FDA’s Submit written/paper submissions as
announcing an opportunity for public follows:
Patient-Focused Drug Development comment on the proposed collection of • Mail/Hand Delivery/Courier (for
initiative. This draft plan also certain information by the Agency. written/paper submissions): Dockets
summarizes the third-party evaluation Under the Paperwork Reduction Act of Management Staff (HFA–305), Food and
of FDA’s implementation of the Benefit- 1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
Risk Framework into FDA’s new drug required to publish notice in the Lane, Rm. 1061, Rockville, MD 20852.
review. Federal Register concerning each • For written/paper comments
The plan also includes an overview of proposed collection of information, submitted to the Dockets Management
FDA’s commitments in PDUFA VI for including each proposed extension of an Staff, FDA will post your comment, as
continued implementation of structured existing collection of information, and well as any attachments, except for
benefit-risk assessment during FY 2018– to allow 60 days for public comment in information submitted, marked and
2022. These commitments include response to the notice. This notice identified, as confidential, if submitted
participating in a meeting to gather solicits comments on the reporting and as detailed in ‘‘Instructions.’’
recordkeeping requirements of our Instructions: All submissions received
stakeholder input on key topics,
regulations implementing the Federal must include the Docket No. FDA–
publishing a draft guidance on benefit-
Import Milk Act (FIMA). 2012–N–0369 for ‘‘Agency Information
risk assessment for new drugs and
DATES: Submit either electronic or Collection Activities; Proposed
biologics, continuing to revise relevant
written comments on the collection of Collection; Comment Request;
Manuals for Policies and Procedures Regulations under the Federal Import
information by June 1, 2018.
and Standard Operating Practices and Milk Act.’’ Received comments, those
ADDRESSES: You may submit comments
Procedures to incorporate benefit-risk filed in a timely manner (see
as follows: Please note that late,
assessment approaches, and conducting ADDRESSES), will be placed in the docket
untimely filed comments will not be
a second evaluation of the and, except for those submitted as
considered. Electronic comments must
implementation of the Benefit-Risk be submitted on or before June 1, 2018. ‘‘Confidential Submissions,’’ publicly
Framework beginning in 2021. In The https://www.regulations.gov viewable at https://www.regulations.gov
addition to these commitments, FDA electronic filing system will accept or at the Dockets Management Staff
also plans to explore additional comments until midnight Eastern Time between 9 a.m. and 4 p.m., Monday
opportunities to enhance our use and at the end of June 1, 2018. Comments through Friday.
communication of benefit-risk received by mail/hand delivery/courier • Confidential Submissions—To
assessments. (for written/paper submissions) will be submit a comment with confidential
considered timely if they are information that you do not wish to be
III. Electronic Access made publicly available, submit your
postmarked or the delivery service
FDA has published the draft plan on acceptance receipt is on or before that comments only as a written/paper
its website: https://www.fda.gov/ date. submission. You should submit two
copies total. One copy will include the
ForIndustry/UserFees/Prescription Electronic Submissions information you claim to be confidential
DrugUserFee/ucm326192.htm. The
Submit electronic comments in the with a heading or cover note that states
period for public comment on the draft ‘‘THIS DOCUMENT CONTAINS
following way:
daltland on DSKBBV9HB2PROD with NOTICES
plan will remain open for 60 days • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
following the publication of this notice. https://www.regulations.gov. Follow the Agency will review this copy, including
After consideration of public comments, instructions for submitting comments. the claimed confidential information, in
FDA will finalize the plan. Throughout Comments submitted electronically, its consideration of comments. The
PDUFA VI, the Agency will update the including attachments, to https:// second copy, which will have the
plan as necessary and post all updates www.regulations.gov will be posted to claimed confidential information
on FDA’s website. the docket unchanged. Because your redacted/blacked out, will be available
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![13994 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices
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 .05 (3 minutes) .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 Under 5 CFR 1320.3(c)(2), the public Dockets Management Staff, 5630 Fishers
collection, we have retained the disclosure of information originally Lane, Rm. 1061, Rockville, MD 20852
currently approved estimated burden. supplied by the Federal Government to between 9 a.m. and 4 p.m., Monday
The estimated number of respondents the recipient for the purpose of through Friday. Publicly available
and hours per response are based on our disclosure to the public is not subject to submissions may be seen in the docket.
experience with the import milk permit review by the Office of Management and FOR FURTHER INFORMATION CONTACT: Julie
program and the average number of Budget under the Paperwork Reduction Finegan, Office of Scientific Integrity,
import milk permit holders over the Act. Under 5 CFR 1320.3(b)(2)), the Office of the Chief Scientist, Food and
past 3 years. Assuming two respondents time, effort, and financial resources Drug Administration, 10903 New
will submit approximately 200 Form necessary to comply with a collection of Hampshire Ave., Bldg. 1, Rm. 4218,
FDA 1996 reports annually for a total of information are excluded from the Silver Spring, MD 20993–0002, 301–
600 responses, and that each response burden estimate if the reporting, 796–8618.
requires 1.5 hours, we estimate the total recordkeeping, or disclosure activities SUPPLEMENTARY INFORMATION:
burden is 600 hours. needed to comply are usual and
The Secretary of Health and Human customary because they would occur in I. Background
Services has the discretion to allow the normal course of business activities. A. Procedural Background
Form FDA 1815, a duly certified Dated: March 27, 2018. On February 18, 1999, the U.S. Food
statement signed by an accredited
Leslie Kux, and Drug Administration (FDA or the
official of a foreign government, to be
Associate Commissioner for Policy. Agency) approved a new drug
submitted in lieu of Forms FDA 1994
[FR Doc. 2018–06595 Filed 3–30–18; 8:45 am] application (NDA) submitted by
and 1995. To date, Form FDA 1815 has
Braintree Laboratories, Inc., (Braintree)
been submitted in lieu of these forms. BILLING CODE 4164–01–P
for prescription (or ‘‘Rx’’) PEG 3350
Because we have not received any
(MiraLAX) (NDA 20–698).
Forms FDA 1994 or 1995 in the last 3
DEPARTMENT OF HEALTH AND Subsequently, FDA approved five
years, we assume no more than one will ANDAs for prescription PEG 3350.1 On
be submitted annually. We also assume HUMAN SERVICES
October 6, 2006, FDA approved a new
each submission requires 0.5 hour for a Food and Drug Administration NDA (NDA 22–015) submitted by
total of 0.5 burden hour annually. Braintree, removing their PEG 3350
We estimate that two respondents will [Docket No. FDA–2008–N–0549] laxative drug product from prescription
submit one Form FDA 1997 report
Prescription Polyethylene Glycol 3350; dispensing requirements of section
annually, for a total of two responses.
Denial of a Hearing and Order 503(b) of the FD&C Act (21 U.S.C.
We estimate the reporting burden to be
Withdrawing Approval of Abbreviated 353(b)).2
2.0 hours per response, for a total Section 503(b)(1) of the FD&C Act
burden of 4 hours. We estimate that two New Drug Applications
requires that a drug which: (1) Because
respondents will submit one Form FDA
AGENCY: Food and Drug Administration,
1993 report annually, for a total of two 1 The Drug Price Competition and Patent Term
HHS.
responses. We estimate the reporting Restoration Act of 1984 (Pub. L. 98–417) (the Hatch-
burden to be 0.5 hour per response, for ACTION: Notice. Waxman Amendments) created new section 505(j)
a total burden of 1 hour. We estimate of the FD&C Act, which established the current
SUMMARY: The Commissioner of Food ANDA approval process. To obtain approval, an
that two respondents will submit one and Drugs (the Commissioner) is ANDA applicant is not required to submit evidence
Form FDA 1815 report annually, for a denying requests for a hearing and to establish the clinical safety and effectiveness of
total of two responses. We estimate the issuing an order withdrawing approval
the drug product; instead, an ANDA relies on FDA’s
reporting burden to be 0.5 hour per previous finding that the reference listed drug is
of abbreviated new drug applications safe and effective. To rely on a previous finding of
response, for a total burden of 1 hour. (ANDAs) for certain prescription safety and effectiveness, an ANDA applicant must
With regard to records maintenance, demonstrate, among other things, that the drug
laxatives with the active ingredient
we estimate that approximately two product described in an ANDA has the same active
polyethylene glycol 3350 (PEG 3350), ingredient(s), indications for use, route of
recordkeepers will spend 0.05 hour
listed in this document, because the administration, dosage form, strength, and labeling
annually maintaining the additional
drug products are misbranded under the as the reference listed drug (section 505(j)(2)(A)(i)–
pasteurization records required by (v) and (j)(4) of the FD&C Act). In addition, the
Federal Food, Drug, and Cosmetic Act
§ 1210.15, for a total of 0.10 hour ANDA applicant must submit evidence that its
(FD&C Act). proposed drug product is bioequivalent to the
annually.
No burden has been estimated for the DATES: This order is applicable May 2, reference listed drug (section 505(j)(2)(A)(iv) of the
daltland on DSKBBV9HB2PROD with NOTICES
2018. FD&C Act).
tagging requirement in § 1210.22 2 On October 10, 2008, Braintree requested that
because the information on the tag is ADDRESSES: For access to the docket, go FDA withdraw approval of the NDA for
either supplied by us (permit number) to https://www.regulations.gov and prescription MiraLAX (NDA 20–698) under 21 CFR
or is disclosed to third parties as a usual insert the docket number, found in 314.150(c) because it had stopped marketing the
product. On February 11, 2009, FDA withdrew
and customary part of the shipper’s brackets in the heading of this approval of the NDA for prescription MiraLAX in
normal business activities (type of document, into the ‘‘Search’’ box and a Federal Register notice (effective March 13,
product, shipper’s name and address). follow the prompts and/or go to the 2009)(74 FR 6896 at 6899 (February 11, 2009)).
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Document Created: 2018-11-01 09:08:12
Document Modified: 2018-11-01 09:08:12
| 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 June 1, 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 13992 |
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