83 FR 49393 - Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 190 (October 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 190 (October 1, 2018)
| Page Range | 49393-49395 | |
| FR Document | 2018-21207 |
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)] [Notices] [Pages 49393-49395] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21207] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3490] Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records 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 information collection provisions of the guidance entitled ``Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' DATES: Submit either electronic or written comments on the collection of information by November 30, 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 November 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. midnight Eastern Time at the end of November 30, 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-2018-N-3490 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records.'' 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 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, [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 [[Page 49394]] 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. Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records OMB Control Number 0910-0811--Extension Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of section 412(a), (b), and (c) of the FD&C Act. These formulas are customarily referred to as ``exempt infant formulas.'' Under part 106 (21 CFR part 106), we established requirements for quality factors for infant formulas and CGMPs, including quality control procedures. This collection of information will help prevent the manufacture of adulterated infant formula, ensure the safety of infant formula, and ensure that the nutrients in infant formula are present in a form that is bioavailable. In the Federal Register of April 15, 2016 (81 FR 22174), we published a notice of availability for the guidance document entitled ``Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements in part 106 for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to nonexempt infant formulas. Persons with access to the internet may obtain the guidance at http://www.fda.gov/FoodGuidances. Our estimate of the burden of the recordkeeping recommendations includes the one-time burden of developing production and in-process control systems and the annual burdens of developing and maintaining production aggregate production and control records, records pertaining to the distribution of infant formula, and records pertaining to regularly scheduled audits. Included in the burden estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. The guidance recommended, to the extent practicable, that respondents include records required by part 106, subparts A, B, C, D, and F for non-exempt infant formulas. Because the records and reporting requirements related to part 106, subparts E and G are not generally applicable to exempt infant formula manufacturers, FDA is not recommending in the guidance that exempt infant formula manufacturers follow these requirements. As such, the records and reporting requirements in part 106, subparts E and G are not part of this information collection. Description of Respondents: The respondent recordkeepers are manufacturers of exempt infant formula. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of records per Total annual Average burden per recordkeeper Total hours recordkeepers recordkeeper records -------------------------------------------------------------------------------------------------------------------------------------------------------- First-Year Annual Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Production and In-Process Control System 3 1 3 40...................................... 120 106.6(c)(5) and 106.100(e)(1) and (e)(3). Controls to Prevent Adulteration due to 3 1 3 6,400................................... 19,200 Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5). --------------------------------------------------------------------------------------------------------- Total First Year Only Hourly Recordkeeping .............. .............. .............. ........................................ 19,320 Burden. -------------------------------------------------------------------------------------------------------------------------------------------------------- Recurring Annual Burden -------------------------------------------------------------------------------------------------------------------------------------------------------- Controls to Prevent Adulteration Caused by 4 1 4 1.5..................................... 6 Facilities--Testing for Radiological Contaminants 106.20(f)(3). Controls to Prevent Adulteration Caused by 4 1 4 0.08 (5 minutes)........................ 0.32 Facilities--Recordkeeping of Testing for Radiological Contaminants 106.20(f)(4) and 106.100(f)(1). Controls to Prevent Adulteration Caused by 3 52 156 0.08 (5 minutes)........................ 12.48 Facilities--Testing for Bacteriological Contaminants 106.20(f)(3). [[Page 49395]] Controls to Prevent Adulteration Caused by 3 52 156 0.08 (5 minutes)........................ 12.48 Facilities--Recordkeeping of Testing for Bacteriological Contaminants 106.20(f)(4) and 106.100(f)(1). Controls to Prevent Adulteration by Equipment 3 52 156 0.21 (13 minutes)....................... 32.76 or Utensils 106.30(d)(1) and 106.100(f)(2). Controls to Prevent Adulteration by Equipment 3 52 156 0.21 (13 minutes)....................... 32.76 or Utensils 106.30(e)(3)(iii) and 106.100(f)(3). Controls to Prevent Adulteration by Equipment 3 52 156 0.19 (11 minutes)....................... 29.64 or Utensils 106.30(f)(2) and 106.100(f)(4). Controls to Prevent Adulteration Due to 3 52 156 520..................................... 81,120 Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5). Controls to Prevent Adulteration Due to 3 2 6 640..................................... 3,840 Automatic (Mechanical or Electronic) Equipment 106.35(c) and 106.100(f)(5). Controls to Prevent Adulteration Caused by 3 52 156 0.17 (10 minutes)....................... 26.52 Ingredients, Containers, and Closures 106.40(g) and 106.100(f)(6). Controls to Prevent Adulteration During 3 52 156 0.23 (14 minutes)....................... 35.88 Manufacturing 106.50 and 106.100(e). Controls to Prevent Adulteration From 3 52 156 0.25 (15 minutes)....................... 39 Microorganisms 106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7). Controls to Prevent Adulteration During 1 12 12 0.25 (15 minutes)....................... 3 Packaging and Labeling of Infant Formula 106.60(c). General Quality Control--Testing 106.91(b)(1), 2 1 2 2....................................... 4 106.91(b)(2) and 106.91(b)(3). General Quality Control 106.91(b)(1), 2 52 104 0.15 (9 minutes)........................ 15.6 106.91(d), and 106.100(e)(5)(i). General Quality Control 106.91(b)(2) 2 52 104 0.15 (9 minutes)........................ 15.6 106.91(d), and 106.100(e)(5)(i). General Quality Control 106.91(b)(3) 2 52 104 0.15 (9 minutes)........................ 15.6 106.91(d), and 106.100(e)(5)(i). Audit Plans and Procedures 106.94--Ongoing 3 1 3 8....................................... 24 Review and Updating of Audits. Audit Plans and Procedures 106.94--Regular 3 52 156 4....................................... 624 Audits. --------------------------------------------------------------------------------------------------------- Total Recurring Recordkeeping Burden...... .............. .............. .............. ........................................ 85,889.64 --------------------------------------------------------------------------------------------------------- Total Recordkeeping Burden............ .............. .............. .............. ........................................ 105,209.64 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information collection, we made a correction since the last OMB approval. While the one-time estimated recordkeeping burden remains as 19,320 hours, we increased the annual estimated recurring recordkeeping burden to 85,889.64 hours due to a calculation error (a 79,561.58 hour increase) for a total recordkeeping burden of 105,209.64 hours. Dated: September 25, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21207 Filed 9-28-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 49393
III. Electronic Access 30, 2018. Comments received by mail/ Dockets Management Staff between 9
Persons with access to the internet hand delivery/courier (for written/paper a.m. and 4 p.m., Monday through
may obtain the draft guidance at either submissions) will be considered timely Friday.
https://www.fda.gov/Drugs/Guidance if they are postmarked or the delivery • Confidential Submissions—To
ComplianceRegulatoryInformation/ service acceptance receipt is on or submit a comment with confidential
Guidances/default.htm, https:// before that date. information that you do not wish to be
www.fda.gov/BiologicsBloodVaccines/ made publicly available, submit your
Electronic Submissions comments only as a written/paper
GuidanceComplianceRegulatory
Submit electronic comments in the submission. You should submit two
Information/Guidances/default.htm, or
following way: copies total. One copy will include the
https://www.regulations.gov.
• Federal eRulemaking Portal: information you claim to be confidential
Dated: September 25, 2018. https://www.regulations.gov. Follow the with a heading or cover note that states
Leslie Kux, instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The
[FR Doc. 2018–21243 Filed 9–28–18; 8:45 am] including attachments, to https:// Agency will review this copy, including
BILLING CODE 4164–01–P www.regulations.gov will be posted to the claimed confidential information, in
the docket unchanged. Because your its consideration of comments. The
comment will be made public, you are second copy, which will have the
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your claimed confidential information
HUMAN SERVICES comment does not include any redacted/blacked out, will be available
confidential information that you or a for public viewing and posted on
Food and Drug Administration third party may not wish to be posted, https://www.regulations.gov. Submit
[Docket No. FDA–2018–N–3490] such as medical information, your or both copies to the Dockets Management
anyone else’s Social Security number, or Staff. If you do not wish your name and
Agency Information Collection confidential business information, such contact information to be made publicly
Activities; Proposed Collection; as a manufacturing process. Please note available, you can provide this
Comment Request; Exempt Infant that if you include your name, contact information on the cover sheet and not
Formula Production: Current Good information, or other information that in the body of your comments and you
Manufacturing Practices, Quality identifies you in the body of your must identify this information as
Control Procedures, Conduct of comments, that information will be ‘‘confidential.’’ Any information marked
Audits, and Records posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
• If you want to submit a comment except in accordance with 21 CFR 10.20
AGENCY: Food and Drug Administration, with confidential information that you
HHS. and other applicable disclosure law. For
do not wish to be made available to the more information about FDA’s posting
ACTION: Notice. public, submit the comment as a of comments to public dockets, see 80
SUMMARY: The Food and Drug written/paper submission and in the FR 56469, September 18, 2015, or access
Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper the information at: https://www.gpo.gov/
announcing an opportunity for public Submissions’’ and ‘‘Instructions’’). fdsys/pkg/FR-2015-09-18/pdf/2015-
comment on the proposed collection of Written/Paper Submissions 23389.pdf.
certain information by the Agency. Docket: For access to the docket to
Submit written/paper submissions as read background documents or the
Under the Paperwork Reduction Act of
follows: electronic and written/paper comments
1995 (PRA), Federal Agencies are • Mail/Hand delivery/Courier (for
required to publish notice in the received, go to https://
written/paper submissions): Dockets www.regulations.gov and insert the
Federal Register concerning each Management Staff (HFA–305), Food and
proposed collection of information, docket number, found in brackets in the
Drug Administration, 5630 Fishers heading of this document, into the
including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852.
existing collection of information, and ‘‘Search’’ box and follow the prompts
• For written/paper comments
to allow 60 days for public comment in and/or go to the Dockets Management
submitted to the Dockets Management
response to the notice. This notice Staff, 5630 Fishers Lane, Rm. 1061,
Staff, FDA will post your comment, as
solicits comments on the information Rockville, MD 20852.
well as any attachments, except for
collection provisions of the guidance FOR FURTHER INFORMATION CONTACT:
information submitted, marked and
entitled ‘‘Guidance for Industry: Exempt identified, as confidential, if submitted Domini Bean, Office of Operations,
Infant Formula Production: Current as detailed in ‘‘Instructions.’’ Food and Drug Administration, Three
Good Manufacturing Practices (CGMPs), Instructions: All submissions received White Flint North, 10A–12M, 11601
Quality Control Procedures, Conduct of must include the Docket No. FDA– Landsdown St., North Bethesda, MD
Audits, and Records and Reports.’’ 2018–N–3490 for ‘‘Agency Information 20852, 301–796–5733, PRAStaff@
DATES: Submit either electronic or Collection Activities; Proposed fda.hhs.gov.
written comments on the collection of Collection; Comment Request; Exempt SUPPLEMENTARY INFORMATION: Under the
information by November 30, 2018. Infant Formula Production: Current PRA (44 U.S.C. 3501–3520), Federal
ADDRESSES: You may submit comments Good Manufacturing Practices (CGMPs), Agencies must obtain approval from the
as follows. Please note that late, Quality Control Procedures, Conduct of Office of Management and Budget
amozie on DSK3GDR082PROD with NOTICES
untimely filed comments will not be Audits, and Records.’’ Received (OMB) for each collection of
considered. Electronic comments must comments, those filed in a timely information they conduct or sponsor.
be submitted on or before November 30, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
2018. The https://www.regulations.gov in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
electronic filing system will accept submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
comments until 11:59 p.m. midnight Submissions,’’ publicly viewable at or requirements that members of the
Eastern Time at the end of November https://www.regulations.gov or at the public submit reports, keep records, or
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![Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 49395
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Total Average
Number of Total
21 CFR section records per annual burden per
recordkeepers hours
recordkeeper records recordkeeper
Controls to Prevent Adulteration Caused by Facili- 3 52 156 0.08 (5 minutes) .... 12.48
ties—Recordkeeping of Testing for Bacteriological
Contaminants 106.20(f)(4) and 106.100(f)(1).
Controls to Prevent Adulteration by Equipment or 3 52 156 0.21 (13 minutes) .. 32.76
Utensils 106.30(d)(1) and 106.100(f)(2).
Controls to Prevent Adulteration by Equipment or 3 52 156 0.21 (13 minutes) .. 32.76
Utensils 106.30(e)(3)(iii) and 106.100(f)(3).
Controls to Prevent Adulteration by Equipment or 3 52 156 0.19 (11 minutes) .. 29.64
Utensils 106.30(f)(2) and 106.100(f)(4).
Controls to Prevent Adulteration Due to Automatic 3 52 156 520 ........................ 81,120
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Due to Automatic 3 2 6 640 ........................ 3,840
(Mechanical or Electronic) Equipment 106.35(c)
and 106.100(f)(5).
Controls to Prevent Adulteration Caused by Ingredi- 3 52 156 0.17 (10 minutes) .. 26.52
ents, Containers, and Closures 106.40(g) and
106.100(f)(6).
Controls to Prevent Adulteration During Manufacturing 3 52 156 0.23 (14 minutes) .. 35.88
106.50 and 106.100(e).
Controls to Prevent Adulteration From Microorga- 3 52 156 0.25 (15 minutes) .. 39
nisms 106.55(d), 106.100(e)(5)(ii), and
106.100(f)(7).
Controls to Prevent Adulteration During Packaging 1 12 12 0.25 (15 minutes) .. 3
and Labeling of Infant Formula 106.60(c).
General Quality Control—Testing 106.91(b)(1), 2 1 2 2 ............................ 4
106.91(b)(2) and 106.91(b)(3).
General Quality Control 106.91(b)(1), 106.91(d), and 2 52 104 0.15 (9 minutes) .... 15.6
106.100(e)(5)(i).
General Quality Control 106.91(b)(2) 106.91(d), and 2 52 104 0.15 (9 minutes) .... 15.6
106.100(e)(5)(i).
General Quality Control 106.91(b)(3) 106.91(d), and 2 52 104 0.15 (9 minutes) .... 15.6
106.100(e)(5)(i).
Audit Plans and Procedures 106.94—Ongoing Re- 3 1 3 8 ............................ 24
view and Updating of Audits.
Audit Plans and Procedures 106.94—Regular Audits 3 52 156 4 ............................ 624
Total Recurring Recordkeeping Burden ............... ........................ ........................ ........................ ............................... 85,889.64
Total Recordkeeping Burden ......................... ........................ ........................ ........................ ............................... 105,209.64
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information DEPARTMENT OF HEALTH AND Federal Register concerning each
collection, we made a correction since HUMAN SERVICES proposed collection of information,
the last OMB approval. While the one- including each proposed extension of an
time estimated recordkeeping burden Food and Drug Administration existing collection of information, and
remains as 19,320 hours, we increased [Docket No. FDA–2018–N–3353] to allow 60 days for public comment in
the annual estimated recurring response to the notice. This notice
recordkeeping burden to 85,889.64 Agency Information Collection solicits comments on the information
hours due to a calculation error (a Activities; Proposed Collection; collection provisions of our reporting
79,561.58 hour increase) for a total Comment Request; Antimicrobial and recordkeeping requirements for
recordkeeping burden of 105,209.64 Animal Drug Distribution Reports and antimicrobial animal drug sales and
hours. Recordkeeping distribution.
Dated: September 25, 2018. AGENCY: Food and Drug Administration, DATES: Submit either electronic or
HHS. written comments on the collection of
Leslie Kux,
information by November 30, 2018.
Associate Commissioner for Policy. ACTION: Notice.
ADDRESSES: You may submit comments
[FR Doc. 2018–21207 Filed 9–28–18; 8:45 am]
SUMMARY: The Food and Drug as follows. Please note that late,
amozie on DSK3GDR082PROD with NOTICES
BILLING CODE 4164–01–P Administration (FDA, Agency, or we) is untimely filed comments will not be
announcing an opportunity for public considered. Electronic comments must
comment on the proposed collection of be submitted on or before November 30,
certain information by the Agency. 2018. The https://www.regulations.gov
Under the Paperwork Reduction Act of electronic filing system will accept
1995 (PRA), Federal Agencies are comments until 11:59 p.m. Eastern Time
required to publish notice in the at the end of November 30, 2018.
VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1](https://thefederalregister.org/doc/83_FR_49583/page/3.svg)
Document Created: 2018-09-29 04:25:53
Document Modified: 2018-09-29 04:25:53
| 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 November 30, 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 49393 |
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