83 FR 55723 - Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 216 (November 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 216 (November 7, 2018)
| Page Range | 55723-55726 | |
| FR Document | 2018-24321 |
[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)] [Notices] [Pages 55723-55726] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24321] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3758] Agency Information Collection Activities; Proposed Collection; Comment Request; Individual Patient Expanded Access Applications: Form FDA 3926 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 (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 individual patient expanded access applications. DATES: Submit either electronic or written comments on the collection of information by January 7, 2019. 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 January 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 7, 2019. 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 [[Page 55724]] 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-3758 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926.'' 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, 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. Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926 OMB Control Number 0910-0814--Extension This information collection supports Agency regulations, associated guidance, and Form FDA 3926 concerning individual patient expanded access. Individual patient expanded access allows an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition, the use of an investigational new drug (IND) outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy. When applicable criteria in Sec. 312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded access) and the criteria in Sec. 312.310(a) (21 CFR 312.310(a)) (which apply specifically to individual patient expanded access, including for emergency use) are met, FDA may permit expanded access. Section 312.305(b) sets forth the submission requirements for all types of expanded access requests. To assist respondents with requirements in Sec. 312.305 we developed Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application) and the guidance document entitled, ``Individual Patient Expanded Access Applications: Form FDA 3926.'' The physician may satisfy some of the submission requirements by referring to information in an existing IND, ordinarily the one held by the investigational drug's manufacturer, if the physician obtains permission from that IND holder. If permission is obtained, the physician should then provide to FDA a letter of authorization (LOA) from the existing IND holder that permits FDA to reference that IND. One of the requirements under Sec. 312.305(b)(2) is that a ``cover sheet'' must be included ``meeting the requirements of Sec. 312.23(a).'' This provision applies to several types of submissions under part 312 (21 CFR part 312), ranging from commercial INDs under Sec. 312.23 that involve large groups of patients enrolled in clinical trials to requests from physicians to use an investigational drug for an individual [[Page 55725]] patient. Sponsors currently use Form FDA 1571 for all types of IND submissions to meet the requirements in Sec. 312.23(a). Concerned that physicians requesting expanded access for an individual patient may encounter difficulty in completing Form FDA 1571 and the associated documents because the form is not tailored to requests for individual patient expanded access, we developed Form FDA 3926 to comply with the IND submission requirements in Sec. Sec. 312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a streamlined means to request expanded access and is available for licensed physicians. FDA considers a completed Form FDA 3926 with the box in Field 10 checked and the form signed by the physician to be a request in accordance with Sec. 312.10 for a waiver of any additional requirements in part 312 for an IND submission, including additional information currently provided in Form FDA 1571 and Form FDA 1572 (Statement of Investigator, which provides the identity and qualifications of the investigator conducting the clinical investigation). Under Sec. 312.310(d), in an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division. Authorization of the emergency use may be given by an FDA official over the telephone, provided the physician explains how the expanded access use will meet the requirements of Sec. Sec. 312.305 and 312.310 and agrees to submit an expanded access application within 15 working days of FDA's initial authorization of the expanded access use (Sec. 312.310(d)). The physician may choose to use Form FDA 3926 for the expanded access application. As explained in the instructions for Form FDA 3926 and discussed in the guidance document, the following information is submitted to FDA: Initials for the patient and date of submission. Type of submission (initial or follow-up submission). Clinical information, including indication, brief clinical history of the patient (age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy), and the reason for requesting the proposed treatment, including an explanation of why the patient lacks other therapeutic options. Treatment information, including the investigational drug's name and the name of the entity supplying the drug (generally the manufacturer), the applicable FDA review division (if known), and the treatment plan. This should include the planned dose, route and schedule of administration, planned duration of treatment, monitoring procedures, and planned modifications to the treatment plan in the event of toxicity. LOA, generally obtained from the entity that is the sponsor of the IND (e.g., commercial sponsor/drug manufacturer) being referenced, if applicable. Physician's qualification statement. An appropriate statement includes medical school attended, year of graduation, medical specialty, State medical license number, current employment, and job title. Alternatively, the relevant portion of the physician's curriculum vitae may be attached. Physician's contact information, including name, physical address, email address, telephone number, facsimile number, and physician's IND number, if previously issued by FDA. Contents of submission (for follow-up/additional submissions), including the type of submission being made. FDA accepts Form FDA 3926 for certain follow-up/additional submissions, which include the following: Initial Written IND Safety Report (Sec. 312.32(c)); Followup to a Written IND Safety Report (Sec. 312.32(d)); Annual Report (Sec. 312.33); Summary of Expanded Access Use (treatment completed) (Sec. 312.310(c)(2)); Change in Treatment Plan (Sec. 312.30); General Correspondence or Response to FDA Request for Information (Sec. 312.41); and Response to Clinical Hold (Sec. 312.42(e)). Request for authorization to use Form FDA 3926 for individual patient expanded access application. Signature of the physician certifying that treatment will not begin until 30 days after FDA receives the completed application and all required material unless the submitting physician receives earlier notification from FDA that the treatment may proceed. The physician agrees not to begin or continue clinical investigations covered by the IND if those studies are placed on clinical hold. The physician also certifies that informed consent will be obtained in compliance with Federal requirements (including FDA's regulations in 21 CFR part 50) and that an institutional review board (IRB) that complies with all Federal requirements (including FDA's regulations in 21 CFR part 56) will be responsible for initial and continuing review and approval of the expanded access use. The physician also acknowledges that in the case of an emergency request, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. The physician agrees to conduct the investigation in accordance with all other applicable regulatory requirements. We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Guidance on Individual Patient Expanded Number of responses per Total annual Average burden per response Total hours Access Applications: Form FDA 3926 respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Expanded access submission elements included 790 3.03 2,394 0.75 (45 mins.).......................... 1,795 in Form FDA 3926. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 are retaining the currently approved burden estimate. The estimates for ``number of respondents,'' ``number of responses per respondent,'' and ``total annual responses'' were obtained from reports and data management systems from the Center for Drug Evaluation and Research (CDER) and from other sources familiar with the number of submissions received for individual patient expanded access use under part 312. The estimates for ``average burden per response'' were based on information CDER provided and personnel of the U.S. Department of Health and Human Services familiar with preparing and reviewing expanded access submissions by practicing physicians. [[Page 55726]] Based on data from the Document Archiving, Reporting and Regulatory Tracking System for the number of submissions to FDA using FDA Form 3926 during fiscal years 2015, 2016, and 2017, we estimate that approximately 790 licensed physicians would use FDA Form 3926 to submit 1.46 requests per physician (respondent) for individual patient expanded access, for a total of 1,153 responses annually. Based on these estimates, FDA calculates the total annual responses to be 2,394 (1,153 requests for individual patient expanded access and 1,241 follow-up submissions) by 790 physicians for an average of 3.03 responses per respondent. FDA estimates the average burden per response to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates the total burden to be 1,795 hours. Dated: October 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24321 Filed 11-6-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices 55723
Staff, 5630 Fishers Lane, Rm. 1061, adherence to those principles into its DEPARTMENT OF HEALTH AND
Rockville, MD 20852. decision-making process. HUMAN SERVICES
You may submit comments on any This draft guidance is being issued to
guidance at any time (see 21 CFR Food and Drug Administration
fulfill a commitment made under the
10.115(g)(5)). Submit written requests Prescription Drug User Fee V agreement [Docket No. FDA–2018–N–3758]
for single copies of the draft guidance to (section IX.B.3 of the document entitled
the Division of Drug Information, Center ‘‘PDUFA Reauthorization Performance Agency Information Collection
for Drug Evaluation and Research, Food Activities; Proposed Collection;
Goals and Procedures Fiscal Years 2013
and Drug Administration, 10001 New Comment Request; Individual Patient
through 2017’’) to promote a better
Hampshire Ave., Hillandale Building, Expanded Access Applications: Form
understanding and increased FDA 3926
4th Floor, Silver Spring, MD 20993–
consistency among the Agency, industry
0002; or to the Office of AGENCY: Food and Drug Administration,
and other stakeholders regarding meta-
Communication, Outreach, and HHS.
Development, Center for Biologics analyses and their role in regulatory
decision-making. ACTION: Notice.
Evaluation and Research, Food and
Drug Administration, 10903 New This draft guidance is being issued SUMMARY: The Food and Drug
Hampshire Ave., Bldg. 71, Rm. 3128, consistent with FDA’s good guidance Administration (FDA, Agency, or we) is
Silver Spring, MD 20993–0002. Send practices regulation (21 CFR 10.115). announcing an opportunity for public
one self-addressed adhesive label to The draft guidance, when finalized, will comment on the proposed collection of
assist that office in processing your represent the current thinking of FDA certain information by the Agency.
requests. See the SUPPLEMENTARY on ‘‘Meta-Analyses of Randomized Under the Paperwork Reduction Act of
INFORMATION section for electronic Controlled Clinical Trials to Evaluate 1995 (PRA), Federal Agencies are
access to the draft guidance document. the Safety of Human Drugs or Biological required to publish notice in the
FOR FURTHER INFORMATION CONTACT: Products.’’ It does not establish any Federal Register concerning each
Scott N. Goldie, Office of Biostatistics, rights for any person and is not binding proposed collection of information,
Center for Drug Evaluation and on FDA or the public. You can use an including each proposed extension of an
Research, Food and Drug alternative approach if it satisfies the existing collection of information, and
Administration, 10903 New Hampshire requirements of the applicable statutes to allow 60 days for public comment in
Ave., Bldg. 21, Rm. 3557, Silver Spring, and regulations. This guidance is not response to the notice. This notice
MD 20993–0002, 301–796–2055; or subject to Executive Order 12866. solicits comments on individual patient
Stephen Ripley, Center for Biologics expanded access applications.
Evaluation and Research, Food and II. Paperwork Reduction Act of 1995 DATES: Submit either electronic or
Drug Administration, 10903 New written comments on the collection of
This draft guidance refers to information by January 7, 2019.
Hampshire Ave., Bldg. 71, Rm. 7301,
previously approved collections of
Silver Spring, MD 20993–0002, 240– ADDRESSES: You may submit comments
information that are subject to review by as follows. Please note that late,
402–7911.
the Office of Management and Budget untimely filed comments will not be
SUPPLEMENTARY INFORMATION: (OMB) under the Paperwork Reduction considered. Electronic comments must
I. Background Act of 1995 (44 U.S.C. 3501–3520). The be submitted on or before January 7,
collections of information in 21 CFR 2019. The https://www.regulations.gov
FDA is announcing the availability of parts 312, 314, and 601 have been electronic filing system will accept
a draft guidance for industry entitled approved under OMB control numbers comments until 11:59 p.m. Eastern Time
‘‘Meta-Analyses of Randomized 0910–0014, 0910–0001, and 0910–0338 at the end of January 7, 2019. Comments
Controlled Clinical Trials to Evaluate respectively. received by mail/hand delivery/courier
the Safety of Human Drugs or Biological
(for written/paper submissions) will be
Products.’’ Evaluating the safety of drug III. Electronic Access
considered timely if they are
products, both before approval and after
Persons with access to the internet postmarked or the delivery service
marketing, is a fundamental
may obtain the draft guidance at either acceptance receipt is on or before that
responsibility of the FDA. This
https://www.fda.gov/Drugs/Guidance date.
evaluation often requires combining and
integrating information from multiple ComplianceRegulatoryInformation/ Electronic Submissions
sources, and meta-analysis is a useful Guidances/default.htm, https:// Submit electronic comments in the
tool for this purpose. www.fda.gov/BiologicsBloodVaccines/ following way:
This draft guidance describes general GuidanceComplianceRegulatory • Federal eRulemaking Portal:
principles of design, conduct, and Information/Guidances/default.htm, or https://www.regulations.gov. Follow the
reporting that FDA intends to apply to https://www.regulations.gov. instructions for submitting comments.
meta-analyses conducted by the Agency, Dated: November 1, 2018. Comments submitted electronically,
and to use as benchmarks when Leslie Kux, including attachments, to https://
evaluating meta-analyses conducted by www.regulations.gov will be posted to
Associate Commissioner for Policy.
sponsors or third parties. The focus of the docket unchanged. Because your
[FR Doc. 2018–24316 Filed 11–6–18; 8:45 am]
the draft guidance is on the evaluation comment will be made public, you are
amozie on DSK3GDR082PROD with NOTICES1
of safety. This draft guidance is not BILLING CODE 4164–01–P solely responsible for ensuring that your
intended to be a reference guide on how comment does not include any
to conduct a meta-analysis. Rather, this confidential information that you or a
draft guidance document discusses the third party may not wish to be posted,
important principles underlying best such as medical information, your or
practices for safety meta-analyses and anyone else’s Social Security number, or
the way that FDA intends to factor confidential business information, such
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![55726 Federal Register / Vol. 83, No. 216 / Wednesday, November 7, 2018 / Notices
Based on data from the Document DATES: Submit either electronic or Collection Activities; Proposed
Archiving, Reporting and Regulatory written comments on the collection of Collection; Comment Request;
Tracking System for the number of information by January 7, 2019. Recordkeeping Requirements for
submissions to FDA using FDA Form ADDRESSES: You may submit comments Microbiological Testing and Corrective
3926 during fiscal years 2015, 2016, and as follows. Please note that late, Measures for Bottled Water.’’ Received
2017, we estimate that approximately untimely filed comments will not be comments, those filed in a timely
790 licensed physicians would use FDA considered. Electronic comments must manner (see ADDRESSES), will be placed
Form 3926 to submit 1.46 requests per be submitted on or before January 7, in the docket and, except for those
physician (respondent) for individual 2019. The https://www.regulations.gov submitted as ‘‘Confidential
patient expanded access, for a total of electronic filing system will accept Submissions,’’ publicly viewable at
1,153 responses annually. Based on comments until 11:59 p.m. Eastern Time https://www.regulations.gov or at the
these estimates, FDA calculates the total at the end of January 7, 2019. Comments Dockets Management Staff between 9
annual responses to be 2,394 (1,153 received by mail/hand delivery/courier a.m. and 4 p.m., Monday through
requests for individual patient (for written/paper submissions) will be Friday.
expanded access and 1,241 follow-up considered timely if they are • Confidential Submissions—To
submissions) by 790 physicians for an postmarked or the delivery service submit a comment with confidential
average of 3.03 responses per acceptance receipt is on or before that information that you do not wish to be
respondent. FDA estimates the average date. made publicly available, submit your
burden per response to be 45 minutes comments only as a written/paper
Electronic Submissions
(0.75 hour). Based on this estimate, FDA submission. You should submit two
calculates the total burden to be 1,795 Submit electronic comments in the copies total. One copy will include the
hours. following way: information you claim to be confidential
• Federal eRulemaking Portal: with a heading or cover note that states
Dated: October 31, 2018.
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Leslie Kux, instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
Associate Commissioner for Policy. Comments submitted electronically, Agency will review this copy, including
[FR Doc. 2018–24321 Filed 11–6–18; 8:45 am] including attachments, to https:// the claimed confidential information, in
BILLING CODE 4164–01–P www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
comment will be made public, you are claimed confidential information
DEPARTMENT OF HEALTH AND solely responsible for ensuring that your redacted/blacked out, will be available
HUMAN SERVICES comment does not include any for public viewing and posted on
confidential information that you or a https://www.regulations.gov. Submit
Food and Drug Administration third party may not wish to be posted, both copies to the Dockets Management
such as medical information, your or Staff. If you do not wish your name and
[Docket No. FDA–2018–N–4130] anyone else’s Social Security number, or contact information to be made publicly
confidential business information, such available, you can provide this
Agency Information Collection as a manufacturing process. Please note
Activities; Proposed Collection; information on the cover sheet and not
that if you include your name, contact in the body of your comments and you
Comment Request; Recordkeeping information, or other information that
Requirements for Microbiological must identify this information as
identifies you in the body of your ‘‘confidential.’’ Any information marked
Testing and Corrective Measures for comments, that information will be
Bottled Water as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
AGENCY: Food and Drug Administration, • If you want to submit a comment and other applicable disclosure law. For
HHS. with confidential information that you more information about FDA’s posting
do not wish to be made available to the of comments to public dockets, see 80
ACTION: Notice. public, submit the comment as a FR 56469, September 18, 2015, or access
written/paper submission and in the the information at: https://www.gpo.gov/
SUMMARY: The Food and Drug manner detailed (see ‘‘Written/Paper
Administration (FDA or Agency) is fdsys/pkg/FR-2015-09-18/pdf/2015-
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
announcing an opportunity for public
comment on the proposed collection of Written/Paper Submissions Docket: For access to the docket to
certain information by the Agency. 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 received, go to https://
required to publish notice in the written/paper submissions): Dockets www.regulations.gov and insert the
Federal Register concerning each Management Staff (HFA–305), Food and docket number, found in brackets in the
proposed collection of information, Drug Administration, 5630 Fishers heading of this document, into the
including each proposed extension of an Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
existing collection of information, and • For written/paper comments and/or go to the Dockets Management
to allow 60 days for public comment in submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
response to the notice. This notice Staff, FDA will post your comment, as Rockville, MD 20852.
amozie on DSK3GDR082PROD with NOTICES1
solicits comments on the procedure by well as any attachments, except for FOR FURTHER INFORMATION CONTACT:
which both domestic and foreign bottled information submitted, marked and Domini Bean, Office of Operations,
water manufacturers that sell bottled identified, as confidential, if submitted Food and Drug Administration, Three
water in the United States maintain as detailed in ‘‘Instructions.’’ White Flint North, 10A–12M, 11601
records of microbiological testing and Instructions: All submissions received Landsdown St., North Bethesda, MD
corrective measures, in addition to must include the Docket No. FDA– 20852, 301–796–5733, PRAStaff@
existing recordkeeping requirements. 2018–N–4130 for ‘‘Agency Information fda.hhs.gov.
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Document Created: 2018-11-07 00:05:05
Document Modified: 2018-11-07 00:05:05
| 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 January 7, 2019. | |
| 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 55723 |
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