82 FR 24718 - Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 102 (May 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 102 (May 30, 2017)
| Page Range | 24718-24720 | |
| FR Document | 2017-11009 |
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)] [Notices] [Pages 24718-24720] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11009] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2010-N-0258] Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 information collection provisions of FDA's regulations for submission of petitions, including food and color additive petitions (FAPs and CAPs) (including labeling) submission of information to a master file in support of petitions, and electronic submission using FDA Form 3503. DATES: Submit either electronic or written comments on the collection of information by July 31, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2017. 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. ADDRESSES: You may submit comments as follows: 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2010-N-0258 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling); Submission of Information to a Master File in Support of Petitions; Electronic Submission Using Food and Drug Administration Form 3503.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 [[Page 24719]] 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected], 301-796- 7726. 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. Submission of Petitions: Food Additive, Color Additive (Including Labeling); Submission of Information to a Master File in Support of Petitions; Electronic Submission Using FDA Form 3503--21 CFR 70.25, 71.1, 171.1, 172, 173, 179, and 180; OMB Control Number 0910-0016-- Extension Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed to be unsafe, unless: (1) The additive and its use, or intended use, are in conformity with a regulation issued under Sec. 409 that describes the condition(s) under which the additive may be safely used; (2) the additive and its use, or intended use, conform to the terms of an exemption for investigational use; or (3) a food contact notification submitted under Sec. 409(h) is effective. FAPs are submitted by individuals or companies to obtain approval of a new food additive or to amend the conditions of use permitted under an existing food additive regulation. Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the information that a petitioner must submit in order to establish that the proposed use of a food additive is safe and to secure the publication of a food additive regulation describing the conditions under which the additive may be safely used. Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling requirements for certain food additives to ensure their safe use. Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a color additive shall be deemed to be unsafe unless the additive and its use are in conformity with a regulation that describes the condition(s) under which the additive may safely be used, or the additive and its use conform to the terms of an exemption for investigational use issued under Sec. 721(f). CAPs are submitted by individuals or companies to obtain approval of a new color additive or a change in the conditions of use permitted for a color additive that is already approved. Section 71.1 of the Agency's regulations (21 CFR 71.1) specifies the information that a petitioner must submit to establish the safety of a color additive and to secure the issuance of a regulation permitting its use. FDA's color additive labeling requirements in Sec. 70.25 (21 CFR 70.25) require that color additives that are to be used in food, drugs, devices, or cosmetics be labeled with sufficient information to ensure their safe use. FDA scientific personnel reviews FAPs to ensure the safety of the intended use of the additive in or on food, or that may be present in food as a result of its use in articles that contact food. Likewise, FDA personnel review CAPs to ensure the safety of the color additive prior to its use in food, drugs, cosmetics, or medical devices. Interested persons may transmit FAP or CAP regulatory submissions in electronic format or paper format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3503. Form FDA 3503 helps the respondent organize their submission to focus on the information needed for FDA's safety review. Form FDA 3503 can also be used to organize information within a master file submitted in support of petitions according to the items listed on the form. Master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden for food and color additive approvals. FDA estimates that the amount of time for respondents to complete FDA Form 3503 will continue to be 1 hour. Description of respondents: Respondents are businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Total Number of Number of Total annual Average burden operating and 21 CFR section/FDA form respondents responses per responses per response Total hours maintenance respondent costs -------------------------------------------------------------------------------------------------------------------------------------------------------- Color Additive Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- 70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 24720]] Food Additive Petitions -------------------------------------------------------------------------------------------------------------------------------------------------------- 171.1................................................... 3 1 3 7,093 21,279 0 FDA Form 3503........................................... 6 1 6 1 6 0 rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr Total............................................... .............. .............. .............. .............. 23,959 $5,600 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs associated with this collection of information. The estimate of burden for food additive or color additive petitions is based on FDA's experience with the petition process. The burden for this information collection has changed since the last OMB approval because the Generally Recognized as Safe affirmations have been removed pursuant to the implementation of ``Substances Generally Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior estimate of the number of petitions received because the average number of petitions received annually has varied little over the past 10 years. The figures for hours per response are based on estimates from experienced persons in the Agency and in industry. Although the estimated hour burden varies with the type of petition submitted, an average petition involves analytical work and appropriate toxicological studies, as well as the work of drafting the petition itself. The burden varies depending on the complexity of the petition, including the amount and types of data needed for scientific analysis. Color additives are subjected to payment of fees for the petitioning process. The listing fee for a color additive petition ranges from $1,600 to $3,000, depending on the intended use of the color additive and the scope of the requested amendment. A complete schedule of fees is set forth in Sec. 70.19. An average of one Category A and one Category B color additive petition is expected per year. The maximum color additive petition fee for a Category A petition is $2,600 and the maximum color additive petition fee for a Category B petition is $3,000. Because an average of 2 CAPs are expected per calendar year, the estimated total annual cost burden to petitioners for this startup cost would be less than or equal to $5,600 ((1 x $2,600) + (1 x $3,000) listing fees = $5,600). There are no capital costs associated with CAPs. The labeling requirements for food and color additives were designed to specify the minimum information needed for labeling in order that food and color manufacturers may comply with all applicable provisions of the FD&C Act and other specific labeling acts administered by FDA. Label information does not require any additional information gathering beyond what is already required to assure conformance with all specifications and limitations in any given food or color additive regulation. Label information does not have any specific recordkeeping requirements unique to preparing the label. Therefore, because labeling requirements under Sec. 70.25 for a particular color additive involve information required as part of the CAP safety review process, the estimate for number of respondents is the same for Sec. 70.25 and Sec. 71.1, and the burden hours for labeling are included in the estimate for Sec. 71.1. Also, because labeling requirements under parts 172, 173, 179, and 180 for particular food additives involve information required as part of the FAP safety review process under Sec. 171.1, the burden hours for labeling are included in the estimate for Sec. 171.1. Dated: May 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11009 Filed 5-26-17; 8:45 am] BILLING CODE 4164-01-P
![24718 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
2017. Time allotted for each required to publish notice in the Written/Paper Submissions
presentation may be limited. If the Federal Register concerning each Submit written/paper submissions as
number of registrants requesting to proposed collection of information, follows:
speak is greater than can be reasonably including each proposed extension of an • Mail/Hand delivery/Courier (for
accommodated during the scheduled existing collection of information, and written/paper submissions): Division of
open public hearing session, FDA may to allow 60 days for public comment in Dockets Management (HFA–305), Food
conduct a lottery to determine the response to the notice. This notice and Drug Administration, 5630 Fishers
speakers for the scheduled open public solicits comments on the information Lane, Rm. 1061, Rockville, MD 20852.
hearing session. The contact person will collection provisions of FDA’s • For written/paper comments
notify interested persons regarding their regulations for submission of petitions, submitted to the Division of Dockets
request to speak by July 14, 2017. including food and color additive Management, FDA will post your
Persons attending FDA’s advisory petitions (FAPs and CAPs) (including comment, as well as any attachments,
committee meetings are advised that the labeling) submission of information to a except for information submitted,
Agency is not responsible for providing master file in support of petitions, and marked and identified, as confidential,
access to electrical outlets. electronic submission using FDA Form if submitted as detailed in
FDA welcomes the attendance of the 3503. ‘‘Instructions.’’
public at its advisory committee
DATES: Submit either electronic or Instructions: All submissions received
meetings and will make every effort to
written comments on the collection of must include the Docket No. FDA–
accommodate persons with disabilities.
2010–N–0258 for ‘‘Agency Information
If you require accommodations due to a information by July 31, 2017. Late,
Collection Activities; Proposed
disability, please contact CAPT Serina untimely filed comments will not be
Collection; Comment Request;
Hunter-Thomas at least 7 days in considered. Electronic comments must
Submission of Petitions: Food Additive,
advance of the meeting. be submitted on or before July 31, 2017.
FDA is committed to the orderly Color Additive (Including Labeling);
The https://www.regulations.gov
conduct of its advisory committee Submission of Information to a Master
electronic filing system will accept
meetings. Please visit our Web site at: File in Support of Petitions; Electronic
comments until midnight Eastern Time
http://www.fda.gov/ Submission Using Food and Drug
at the end of July 31, 2017. Comments
AdvisoryCommittees/AboutAdvisory Administration Form 3503.’’ Received
received by mail/hand delivery/courier
Committees/ucm111462.htm for comments, those filed in a timely
(for written/paper submissions) will be
procedures on public conduct during manner (see DATES), will be placed in
considered timely if they are
advisory committee meetings. the docket and, except for those
postmarked or the delivery service
Notice of this meeting is given under submitted as ‘‘Confidential
acceptance receipt is on or before that
the Federal Advisory Committee Act (5 Submissions,’’ publicly viewable at
date.
U.S.C. app. 2). https://www.regulations.gov or at the
ADDRESSES: You may submit comments Division of Dockets Management
Dated: May 23, 2017. as follows: between 9 a.m. and 4 p.m., Monday
Anna K. Abram, through Friday.
Deputy Commissioner for Policy, Planning, Electronic Submissions • Confidential Submissions—To
Legislation, and Analysis. submit a comment with confidential
Submit electronic comments in the
[FR Doc. 2017–10976 Filed 5–26–17; 8:45 am] information that you do not wish to be
following way:
BILLING CODE 4164–01–P made publicly available, submit your
• Federal eRulemaking Portal: comments only as a written/paper
https://www.regulations.gov. Follow the submission. You should submit two
DEPARTMENT OF HEALTH AND instructions for submitting comments. copies total. One copy will include the
HUMAN SERVICES Comments submitted electronically, information you claim to be confidential
including attachments, to https:// with a heading or cover note that states
Food and Drug Administration www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS
[Docket No FDA–2010–N–0258] the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The
comment will be made public, you are Agency will review this copy, including
Agency Information Collection solely responsible for ensuring that your the claimed confidential information, in
Activities; Proposed Collection; comment does not include any its consideration of comments. The
Comment Request; Submission of confidential information that you or a second copy, which will have the
Petitions: Food Additive, Color third party may not wish to be posted, claimed confidential information
Additive (Including Labeling), such as medical information, your or redacted/blacked out, will be available
Submission of Information to a Master anyone else’s Social Security number, or for public viewing and posted on
File in Support of Petitions; and confidential business information, such https://www.regulations.gov. Submit
Electronic Submission Using Food and as a manufacturing process. Please note both copies to the Division of Dockets
Drug Administration Form 3503 that if you include your name, contact Management. If you do not wish your
information, or other information that name and contact information to be
AGENCY: Food and Drug Administration, identifies you in the body of your
HHS. made publicly available, you can
comments, that information will be provide this information on the cover
ACTION: Notice. posted on https://www.regulations.gov. sheet and not in the body of your
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY: The Food and Drug • If you want to submit a comment comments and you must identify this
Administration (FDA, Agency, or we) is with confidential information that you information as ‘‘confidential.’’ Any
announcing an opportunity for public do not wish to be made available to the information marked as ‘‘confidential’’
comment on the proposed collection of public, submit the comment as a will not be disclosed except in
certain information by the Agency. written/paper submission and in the accordance with 21 CFR 10.20 and other
Under the Paperwork Reduction Act of manner detailed (see ‘‘Written/Paper applicable disclosure law. For more
1995 (the PRA), Federal Agencies are Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of
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![24720 Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total
Number of Average
Number of Total annual operating and
21 CFR section/FDA form responses per burden per Total hours
respondents responses maintenance
respondent response costs
Food Additive Petitions
171.1 ........................................................ 3 1 3 7,093 21,279 0
FDA Form 3503 ....................................... 6 1 6 1 6 0
Total .................................................. ........................ ........................ ........................ ........................ 23,959 $5,600
1 There are no capital costs associated with this collection of information.
The estimate of burden for food minimum information needed for SUMMARY: The Food and Drug
additive or color additive petitions is labeling in order that food and color Administration (FDA or Agency)
based on FDA’s experience with the manufacturers may comply with all announces a forthcoming public
petition process. The burden for this applicable provisions of the FD&C Act advisory committee meeting of the
information collection has changed and other specific labeling acts Pediatric Oncology Subcommittee of the
since the last OMB approval because the administered by FDA. Label information Oncologic Drugs Advisory Committee.
Generally Recognized as Safe does not require any additional The general function of the committee is
affirmations have been removed information gathering beyond what is to provide advice and recommendations
pursuant to the implementation of already required to assure conformance to the Agency on FDA’s regulatory
‘‘Substances Generally Recognized as with all specifications and limitations in issues. The meeting will be open to the
Safe; Final Rule,’’ August 17, 2016 (81 any given food or color additive public. FDA is establishing a docket for
FR 54960), 21 CFR parts 20, 25, 170, regulation. Label information does not public comment on this document.
184, 186, and 570. FDA is retaining its have any specific recordkeeping
prior estimate of the number of petitions DATES: The public meeting will be held
requirements unique to preparing the
received because the average number of on June 21, 2017, from 8 a.m. to 3:15
label. Therefore, because labeling
petitions received annually has varied p.m. and June 22, 2017, from 8 a.m. to
requirements under § 70.25 for a
little over the past 10 years. The figures 12 noon.
particular color additive involve
for hours per response are based on information required as part of the CAP ADDRESSES: FDA White Oak Campus,
estimates from experienced persons in safety review process, the estimate for 10903 New Hampshire Ave., Building
the Agency and in industry. Although number of respondents is the same for 31 Conference Center, the Great Room
the estimated hour burden varies with § 70.25 and § 71.1, and the burden hours (Rm. 1503), Silver Spring, MD 20993–
the type of petition submitted, an for labeling are included in the estimate 0002. Answers to commonly asked
average petition involves analytical for § 71.1. Also, because labeling questions including information
work and appropriate toxicological requirements under parts 172, 173, 179, regarding special accommodations due
studies, as well as the work of drafting and 180 for particular food additives to a disability, visitor parking, and
the petition itself. The burden varies involve information required as part of transportation may be accessed at:
depending on the complexity of the the FAP safety review process under https://www.fda.gov/
petition, including the amount and § 171.1, the burden hours for labeling AdvisoryCommittees/AboutAdvisory
types of data needed for scientific are included in the estimate for § 171.1. Committees/ucm408555.htm.
analysis.
Color additives are subjected to Dated: May 23, 2017. FDA is establishing a docket for
payment of fees for the petitioning Anna K. Abram, public comment on this meeting. The
process. The listing fee for a color Deputy Commissioner for Policy, Planning, docket number is FDA–2017–N–2731.
additive petition ranges from $1,600 to Legislation, and Analysis. The docket will close on June 20, 2017.
$3,000, depending on the intended use [FR Doc. 2017–11009 Filed 5–26–17; 8:45 am] Submit either electronic or written
of the color additive and the scope of BILLING CODE 4164–01–P
comments on this public meeting by
the requested amendment. A complete June 20, 2017. Late, untimely filed
schedule of fees is set forth in § 70.19. comments will not be considered.
An average of one Category A and one DEPARTMENT OF HEALTH AND Electronic comments must be submitted
Category B color additive petition is HUMAN SERVICES on or before June 20, 2017. The https://
expected per year. The maximum color www.regulations.gov electronic filing
additive petition fee for a Category A Food and Drug Administration system will accept comments until
petition is $2,600 and the maximum [Docket No. FDA–2017–N–2731] midnight eastern time, June 20, 2017.
color additive petition fee for a Category Comments received by mail/hand
B petition is $3,000. Because an average Pediatric Oncology Subcommittee of delivery/courier for written/paper
of 2 CAPs are expected per calendar the Oncologic Drugs Advisory submissions will be considered timely if
year, the estimated total annual cost Committee; Notice of Meeting; they are postmarked or the delivery
sradovich on DSK3GMQ082PROD with NOTICES
burden to petitioners for this startup Establishment of a Public Docket; service acceptance receipt is on or
cost would be less than or equal to Request for Comments before that date.
$5,600 ((1 × $2,600) + (1 × $3,000) AGENCY: Food and Drug Administration, Comments received on or before June
listing fees = $5,600). There are no HHS. 7, 2017, will be provided to the
capital costs associated with CAPs. The committee. Comments received after
ACTION: Notice; establishment of a
labeling requirements for food and color that date will be taken into
public docket; request for comments.
additives were designed to specify the consideration by the Agency.
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Document Created: 2018-11-08 08:54:55
Document Modified: 2018-11-08 08:54:55
| 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 July 31, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2017. 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. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected], 301-796- 7726. | |
| FR Citation | 82 FR 24718 |
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