83 FR 42127 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 161 (August 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 161 (August 20, 2018)
| Page Range | 42127-42130 | |
| FR Document | 2018-17860 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Notices] [Pages 42127-42130] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17860] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0248] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level 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 process for formally resolving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level. DATES: Submit either electronic or written comments on the collection of information by October 19, 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 October 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 19, 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''). [[Page 42128]] Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2012-N-0248 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level.'' 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: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 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 Formal Dispute Resolution; Appeals Above the Division Level OMB Control Number 0910-0430--Extension This information collection approval request is for FDA guidance on the process for formally resolving scientific and procedural disputes in FDA's CDER and CBER that cannot be resolved at the division level. The guidance document describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue or issues presented. The guidance document provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (Sec. 10.75 (21 CFR 10.75)) and dispute resolution during the investigational new drug (IND) process (Sec. 312.48 (21 CFR 312.48)) and the new drug application/abbreviated new drug application (NDA/ANDA) process (Sec. 314.103 (21 CFR 314.103)). In addition, the guidance document provides information on how the Agency will interpret and apply the specific Prescription Drug User Fee Act (PDUFA) goals for major dispute resolution associated with the development and review of PDUFA products. Existing regulations, which appear primarily in parts 10, 312, and 314 (21 CFR parts 10, 312, and 314), establish procedures for the resolution of scientific and procedural disputes between interested persons and the Agency, CDER, and CBER. All Agency decisions on such matters are based on information in the administrative file (Sec. 10.75(d)). In general, the information in an administrative file is collected under existing regulations in part 312 (OMB control number 0910-0014), part 314 (OMB control number 0910-0001), and part 601 (21 CFR part 601) (OMB control number 0910-0338), which specify the information manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of drugs and biological products. This information is usually submitted as part of an IND, NDA, or biologics license application (BLA), or as a supplement to an approved application. Although FDA already possesses in the administrative file the information that would form the basis of a decision on a matter in dispute resolution, the submission of information regarding the request itself and the data and information that the requestor relies on in the appeal would facilitate timely resolution of the dispute. The guidance document [[Page 42129]] describes the following collections of information not expressly specified under existing regulations: The submission of the request for dispute resolution as an amendment to the application for the underlying product, including the submission of supporting information with the request for dispute resolution. Agency regulations ((Sec. Sec. 312.23(a)(11) and (d) (21 CFR 312.23(a)(11) and (d), 314.50 (21 CFR 314.50), 314.94 (21 CFR 314.94), and 601.2 (21 CFR 601.2)) state that information provided to the Agency as part of an IND, NDA, ANDA, or BLA must be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs and Form FDA 356h must accompany submissions under NDAs, ANDAs, and BLAs. Both forms have valid OMB control numbers as follows: Form FDA 1571 (OMB control number 0910-0014) and Form FDA 356h (OMB control number 0910-0338). In the guidance document, CDER and CBER ask that a request for formal dispute resolution be submitted as an amendment to the application for the underlying product and that it be submitted to the Agency in triplicate with the appropriate form attached, either Form FDA 1571 or Form FDA 356h. The Agency recommends that a request be submitted as an amendment in this manner for two reasons: (1) To ensure that each request is kept in the administrative file with the entire underlying application; and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the appropriate Agency official to monitor progress on the resolution of the dispute and to ensure that appropriate steps will be taken in a timely manner. CDER and CBER have determined and the guidance document recommends that the following information should be submitted to the appropriate center with each request for dispute resolution so that the center may quickly and efficiently respond to the request: (1) A brief but comprehensive statement of each issue to be resolved, including a description of the issue, the nature of the issue (i.e., scientific, procedural, or both), possible solutions based on information in the administrative file, whether informal dispute resolution was sought prior to the formal appeal, whether advisory committee review is sought, and the expected outcome; (2) a statement identifying the review division/office that issued the original decision on the matter and, if applicable, the last Agency official that attempted to formally resolve the matter; (3) a list of documents in the administrative file or additional copies of such documents that are deemed necessary for resolution of the issue or issues; and (4) a statement that the previous supervisory level has already had the opportunity to review all of the material relied on for dispute resolution. The information the Agency suggests submitting with a formal request for dispute resolution consists of: (1) Statements describing the issue from the perspective of the person with a dispute; (2) brief statements describing the history of the matter; and (3) the documents previously submitted to FDA under an OMB approved collection of information. Based on FDA's experience with dispute resolution, the Agency expects that most persons seeking formal dispute resolution will have gathered the materials listed previously when identifying the existence of a dispute with the Agency. Consequently, FDA anticipates that the collection of information attributed solely to the guidance document will be minimal. Provided in this document is an estimate of the annual reporting burden for requests for dispute resolution. Based on data collected from review divisions and offices within CDER and CBER, FDA estimates that approximately 12 sponsors and applicants (respondents) will submit requests for formal dispute resolution to CDER annually and approximately one respondent will submit requests for formal dispute resolution to CBER annually. The total annual responses are the total number of requests submitted to CDER and CBER in 1 year, including requests for dispute resolution that a single respondent submits more than one time. FDA estimates that CDER receives approximately 17 requests annually and CBER receives approximately 1 request annually. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for formal dispute resolution in accordance with the guidance document, including the time it takes to gather and copy brief statements describing the issue from the perspective of the person with the dispute, brief statements describing the history of the matter, and supporting information that has already been submitted to the Agency. Based on experience, FDA estimates that approximately 8 hours, on average, would be needed per response. Therefore, FDA estimates that 8 hours will be spent per year by respondents requesting formal dispute resolution in accordance with the guidance document. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Requests for formal dispute Number of responses per Total annual Average burden Total hours resolution respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- CDER............................ 12 1.42 17 8 136 CBER............................ 1 1 1 8 8 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 144 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 42130]] The burden for this information collection has changed since the last OMB approval. Our burden estimate reflects a decrease in burden by 14 records and 112 hours. We attribute this adjustment to a decrease in the number of requests received over the last few years. Dated: August 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17860 Filed 8-17-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices 42127
Ave., Bldg. 66, Rm. G642, Silver Spring, the general nature of the evidence or comment on the proposed collection of
MD 20993–0002, Aden.Asefa@ arguments they wish to present, the certain information by the Agency.
fda.hhs.gov, 301–796–0400, or FDA names and addresses of proposed Under the Paperwork Reduction Act of
Advisory Committee Information Line, participants, and an indication of the 1995 (PRA), Federal Agencies are
1–800–741–8138 (301–443–0572 in the approximate time requested to make required to publish notice in the
Washington, DC area). A notice in the their presentation on or before Federal Register concerning each
Federal Register about last minute September 12, 2018. Time allotted for proposed collection of information,
modifications that impact a previously each presentation may be limited. If the including each proposed extension of an
announced Advisory Committee number of registrants requesting to existing collection of information, and
meeting cannot always be published speak is greater than can be reasonably to allow 60 days for public comment in
quickly enough to provide timely accommodated during the scheduled response to the notice. This notice
notice. Therefore, you should always open public hearing session, FDA may solicits comments on the process for
check the Agency’s website at https:// conduct a lottery to determine the formally resolving scientific and
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public procedural disputes in the Center for
default.htm and scroll down to the hearing session. The contact person will Drug Evaluation and Research (CDER)
appropriate advisory committee meeting notify interested persons regarding their and the Center for Biologics Evaluation
link, or call the advisory committee request to speak by September 13, 2018. and Research (CBER) that cannot be
information line to learn about possible Persons attending FDA’s advisory resolved at the division level.
modifications before coming to the committee meetings are advised that the DATES: Submit either electronic or
meeting. Agency is not responsible for providing written comments on the collection of
SUPPLEMENTARY INFORMATION: access to electrical outlets. information by October 19, 2018.
Agenda: On September 27, 2018, the FDA welcomes the attendance of the ADDRESSES: You may submit comments
Committee will discuss, make public at its advisory committee as follows. Please note that late,
recommendations, and vote on the meetings and will make every effort to untimely filed comments will not be
premarket approval application accommodate persons with disabilities. considered. Electronic comments must
sponsored by Sequent Medical, Inc. for If you require accommodations due to a be submitted on or before October 19,
the Woven Endobridge (WEB) disability, please contact Artair Mallett 2018. The https://www.regulations.gov
Aneurysm Embolization System, which at Artair.Mallett@fda.hhs.gov or 301– electronic filing system will accept
is intended to treat wide-neck 796–9638 at least 7 days in advance of comments until midnight Eastern Time
intracranial aneurysms arising or the meeting. at the end of October 19, 2018.
located at a vessel bifurcation. The WEB FDA is committed to the orderly Comments received by mail/hand
device is being evaluated in the WEB conduct of its advisory committee delivery/courier (for written/paper
Intrasaccular Therapy Study (WEB–IT): meetings. Please visit our website at submissions) will be considered timely
a multicenter, prospective, non- https://www.fda.gov/Advisory if they are postmarked or the delivery
randomized investigation. The Committees/AboutAdvisoryCommittees/ service acceptance receipt is on or
Committee will be asked to review the ucm111462.htm for procedures on before that date.
clinical data from the WEB–IT study to public conduct during advisory
help the Agency assess the safety and committee meetings. Electronic Submissions
effectiveness of the device for the Notice of this meeting is given under Submit electronic comments in the
proposed indications for use. the Federal Advisory Committee Act (5 following way:
FDA intends to make background U.S.C. app. 2). • Federal eRulemaking Portal:
material available to the public no later Dated: August 14, 2018. https://www.regulations.gov. Follow the
than 2 business days before the meeting. Leslie Kux, instructions for submitting comments.
If FDA is unable to post the background Associate Commissioner for Policy. Comments submitted electronically,
material on its website prior to the [FR Doc. 2018–17867 Filed 8–17–18; 8:45 am]
including attachments, to https://
meeting, the background material will www.regulations.gov will be posted to
BILLING CODE 4164–01–P
be made publicly available at the the docket unchanged. Because your
location of the advisory committee comment will be made public, you are
meeting, and the background material DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
will be posted on FDA’s website after HUMAN SERVICES comment does not include any
the meeting. Background material is confidential information that you or a
available at https://www.fda.gov/ Food and Drug Administration third party may not wish to be posted,
AdvisoryCommittees/Calendar/ such as medical information, your or
default.htm. Scroll down to the [Docket No. FDA–2012–N–0248] anyone else’s Social Security number, or
appropriate Advisory Committee confidential business information, such
Agency Information Collection
meeting link. as a manufacturing process. Please note
Activities; Proposed Collection;
Procedure: Interested persons may that if you include your name, contact
Comment Request; Guidance for
present data, information, or views, information, or other information that
Industry on Formal Dispute
orally or in writing, on issues pending identifies you in the body of your
Resolution; Appeals Above the
before the committee. Written comments, that information will be
Division Level
submissions may be made to the contact posted on https://www.regulations.gov.
daltland on DSKBBV9HB2PROD with NOTICES
person on or before September 20, 2018. AGENCY: Food and Drug Administration, • If you want to submit a comment
Oral presentations from the public will HHS. with confidential information that you
be scheduled between approximately 1 ACTION: Notice. do not wish to be made available to the
p.m. and 2 p.m. Those individuals public, submit the comment as a
interested in making formal oral SUMMARY: The Food and Drug written/paper submission and in the
presentations should notify the contact Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper
person and submit a brief statement of announcing an opportunity for public Submissions’’ and ‘‘Instructions’’).
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![42130 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Notices
The burden for this information Request for Samples and Protocols or absent to be submitted to the CBER
collection has changed since the last Director at the time of initial
OMB Control Number 0910–0206—
OMB approval. Our burden estimate distribution of each lot.
Extension Section 660.46(a) contains
reflects a decrease in burden by 14
records and 112 hours. We attribute this This information collection supports requirements as to the frequency of
adjustment to a decrease in the number Agency regulations. Under section 351 submission of samples from each lot of
of requests received over the last few of the Public Health Service Act (42 Hepatitis B Surface Antigen product,
years. U.S.C. 262), FDA has the responsibility and § 660.46(b) contains the
to issue regulations that prescribe requirements as to the submission of a
Dated: August 14, 2018.
standards designed to ensure the safety, protocol containing specific information
Leslie Kux, purity, and potency of biological along with each required sample. For
Associate Commissioner for Policy. products and to ensure that the § 660.46 products subject to official
[FR Doc. 2018–17860 Filed 8–17–18; 8:45 am] biologics licenses for such products are release by CBER, one sample from each
BILLING CODE 4164–01–P only issued when a product meets the filling of each lot is required to be
prescribed standards. Under § 610.2 (21 submitted along with a protocol
CFR 610.2), the Center for Biologics consisting of a summary of the history
DEPARTMENT OF HEALTH AND Evaluation and Research (CBER) or the or manufacture of the product,
HUMAN SERVICES Center for Drug Evaluation and Research including all results of each test for
may at any time require manufacturers which test results are requested by
Food and Drug Administration of licensed biological products to CBER. After notification of official
submit to FDA samples of any lot along release is received, one sample along
[Docket No. FDA–2018–N–3038] with the protocols showing the results with a protocol is required to be
of applicable tests prior to distributing submitted at 90-day intervals. In
Agency Information Collection the lot of the product. In addition to addition, samples, which must be
Activities; Submission for Office of § 610.2, there are other regulations that accompanied by a protocol, may at any
Management and Budget Review; require the submission of samples and time be required to be submitted to
Comment Request; Request for protocols for specific licensed biological CBER if continued evaluation is deemed
Samples and Protocols products: 21 CFR 660.6 (Antibody to necessary.
AGENCY: Food and Drug Administration, Hepatitis B Surface Antigen); 21 CFR Samples and protocols are required by
660.36 (Reagent Red Blood Cells); and FDA to help ensure the safety, purity, or
HHS.
21 CFR 660.46 (Hepatitis B Surface potency of the product because of the
ACTION: Notice. Antigen). potential lot-to-lot variability of a
Section 660.6(a) provides product produced from living
SUMMARY: The Food and Drug
requirements for the frequency of organisms. In cases of certain biological
Administration (FDA, Agency, or we) is
submission of samples from each lot of products (e.g., Albumin, Plasma Protein
announcing that a proposed collection Antibody to Hepatitis B Surface Antigen Fraction, and therapeutic biological
of information has been submitted to the product, and § 660.6(b) provides the products) that are known to have lot-to-
Office of Management and Budget requirements for the submission of a lot consistency, official lot release is not
(OMB) for review and clearance under protocol containing specific information normally required. However,
the Paperwork Reduction Act of 1995. along with each required sample. For submissions of samples and protocols of
DATES: Fax written comments on the § 660.6 products subject to official these products may still be required for
collection of information by September release by CBER, one sample from each surveillance, licensing, and export
19, 2018. filling of each lot is required to be purposes, or in the event that FDA
ADDRESSES: To ensure that comments on submitted along with a protocol obtains information that the
the information collection are received, consisting of a summary of the history manufacturing process may not result in
OMB recommends that written of manufacture of the product, consistent quality of the product.
comments be faxed to the Office of including all results of each test for The following burden estimate is for
Information and Regulatory Affairs, which test results are requested by the protocols required to be submitted
OMB, Attn: FDA Desk Officer, Fax: 202– CBER. After official release is no longer with each sample. The collection of
395–7285, or emailed to oira_ required, one sample along with a samples is not a collection of
submission@omb.eop.gov. All protocol is required to be submitted at information under 5 CFR 1320.3(h)(2).
comments should be identified with the 90-day intervals. In addition, samples, Respondents to the collection of
OMB control number 0910–0206. Also which must be accompanied by a information under § 610.2 are
include the FDA docket number found protocol, may at any time be required to manufacturers of licensed biological
in brackets in the heading of this be submitted to CBER if continued products. Respondents to the collection
document. evaluation is deemed necessary. of information under §§ 660.6(b),
Section 660.36(a) requires, after each 660.36(a)(2) and (b), and 660.46(b) are
FOR FURTHER INFORMATION CONTACT: Ila routine establishment inspection by manufacturers of the specific products
Mizrachi, Office of Operations, Food FDA, the submission of samples from a referenced previously in this document.
and Drug Administration, Three White lot of final Reagent Red Blood Cell The estimated number of respondents
Flint North, 10A–12M, 11601 product along with a protocol for each regulation is based on the
Landsdown St., North Bethesda, MD containing specific information. Section annual number of manufacturers that
daltland on DSKBBV9HB2PROD with NOTICES
20852, 301–796–7726, PRAStaff@ 660.36(a)(2) requires that a protocol submitted samples and protocols for
fda.hhs.gov. contain information including, but not biological products including
SUPPLEMENTARY INFORMATION: In limited to, manufacturing records, submissions for lot release, surveillance,
compliance with 44 U.S.C. 3507, FDA certain test records, and identity test licensing, or export. Based on
has submitted the following proposed results. Section 660.36(b) requires a information obtained from FDA’s
collection of information to OMB for copy of the antigenic constitution database system, approximately 79
review and clearance. matrix specifying the antigens present manufacturers submitted samples and
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Document Created: 2018-08-18 01:28:40
Document Modified: 2018-08-18 01:28:40
| 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 October 19, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 42127 |
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