83 FR 5107 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 24 (February 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 24 (February 5, 2018)
| Page Range | 5107-5109 | |
| FR Document | 2018-02234 |
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)] [Notices] [Pages 5107-5109] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02234] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2428] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 7, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0284. Also include the FDA docket number found in brackets in the heading of this document. 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, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Animal Drug Adverse Event Reporting and Recordkeeping--21 U.S.C. 360b(l), 21 CFR 510.301, and 514.80 OMB Control Number 0910-0284--Extension With regard to adverse events and product/manufacturing defects associated with approved new animal drugs, section 512(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l)) requires applicants with approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to establish and maintain records and reports of data relating to experience with uses of such drug, or with respect to animal feeds bearing or containing such drug, to facilitate a determination under section 512(e) as to whether there may be grounds for suspending or withdrawing approval of the NADA or ANADA under section 512(e) or 512(m)(4). Sections 571(e)(3) and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2)) require that applicants with conditionally approved new animal drug applications (CNADAs) maintain adequate records and make reports in accordance with a regulation or order issued under section 512(l). Finally, section 512(m)(5) of the FD&C Act requires an applicant for a license to manufacture animal feeds bearing or containing new animal drugs to maintain adequate records and make reports ``as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine'' whether there may be grounds for suspending or withdrawing approval of the new animal drug under section 512(e) or a license to manufacture animal feeds bearing or containing new animal drugs under section 512(m)(4). Section 514.80 of our regulations (21 CFR 514.80) sets forth the recordkeeping and reporting requirements for applicants and nonapplicants of approved NADAs and ANADAs. Section 510.301 of our regulations (21 CFR 510.301) sets forth the recordkeeping and reporting requirements for licensed medicated feed manufacturing facilities. Recordkeeping and reporting requirements for applicants of approved NADAs and ANADAs. Section 514.80 requires applicants to keep records of and report to us data, studies, and other information concerning experience with new animal drugs for each approved NADA and ANADA. Following complaints from animal owners or veterinarians or following their own detection of a problem, applicants are required to submit adverse event reports and product defect reports under Sec. 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) on Form FDA 1932. Form FDA 1932a (the voluntary reporting form) is used by veterinarians and the general public to submit adverse event reports, product defects, and lack of effectiveness complaints directly to FDA. Form FDA 2301 is used by applicants to submit the required transmittal of periodic reports (Sec. 514.80(b)(4)); special drug experience reports (Sec. 514.80(b)(5)(i)); promotional material for new animal drugs (Sec. 514.80(b)(5)(ii)); and distributor statements (Sec. 514.80(b)(5)(iii)). We review the records and reports required in Sec. 514.80 and the voluntary reports to facilitate a determination under section 512(e) of the FD&C Act as to whether there may be grounds for suspending or withdrawing approval of the new animal drug. We have made minor editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. Submitters are already reporting adverse drug events associated with compounded products on Form FDA 1932a. The clarifications include: the addition of a new question, ``Is this a compounded product?''; the addition of a new field to allow the submitter to provide product strength, ``Strength of Active Ingredient(s)''; modifying the title of the existing field requesting the name of manufacturer, so that it reads, ``Name of Manufacturer or Compounding Pharmacy/Compounder of Suspected Product''; and a request for contact information for the manufacturer or compounder. We estimate that the revisions will not change the average amount of time necessary to complete the form. [[Page 5108]] Recordkeeping and reporting requirements for applicants of CNADAs. As noted, sections 571(e)(3) and 512(e)(2) of the FD&C Act require that applicants for CNADAs maintain adequate records and make reports in accordance with a regulation or order issued under section 512(l) of the FD&C Act. Moreover, section 512(l) requires submission of such information as required ``by general regulation, or by order . . .'' Conditional approval letters explicitly establish an order requiring the submission of postmarketing information in accordance with the requirements of Sec. 514.80. Applicants submit adverse event reports and product defect reports on Form FDA 1932. Recordkeeping and reporting requirements for licensed medicated feed manufacturing facilities. Section 510.301 requires a licensed medicated feed manufacturer to keep records of and report to us information concerning experience with animal feeds bearing or containing approved new animal drugs. Under Sec. 510.301(a), a licensed medicated feed manufacturer must immediately report to us information concerning any mixup in the new animal drug or its labeling; any bacterial or significant chemical, physical, or other change or deterioration in a drug; and any failure of one or more distributed batches of a drug to meet the specifications established for it. Under Sec. 510.301(b), a licensed medicated feed manufacturer must report to us within 15 working days of receipt of information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof, and any unusual failure of the new animal drug to exhibit its expected pharmacological activity. OMB initially approved the information collection provisions of Sec. 510.301 under control number 0910-0012. That approval was subsequently consolidated into this collection in 2004. We reviewed the records and reports required by Sec. 510.301 to facilitate a determination as to whether there may be grounds for suspending or withdrawing approval of the new animal drug under section 512(e) of the FD&C Act, or grounds for revoking a license to manufacture medicated feed under section 512(m)(4). Since the consolidation of the 0910-0012 collection into this collection in 2004, we have included the estimated number of medicated feed adverse event reports as part of our estimate of the number of all mandatory adverse event reports for new animal drugs. To improve the clarity of our estimates, we have added a row to table 1, on which we separately report our estimates of medicated feed reports. The continuous monitoring of approved NADAs, ANADAs, CNADAs, and animal feeds bearing or containing new animal drugs affords the primary means by which we obtain information regarding potential problems with the safety and efficacy of marketed approved new animal drugs, as well as potential product/manufacturing problems. Postapproval marketing surveillance is important because data previously submitted to us may not be adequate as animal drug effects can change over time and less apparent effects may take years to manifest. Description of respondents: Respondents to this collection of information are animal drug manufacturers with approved NADAs, ANADAs, or CNADAs, as well as licensed commercial feed mills and licensed mixer-feeders. In the Federal Register of July 18, 2017 (82 FR 32829), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited and therefore will not be discussed in this document. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Average Activity FDA Form respondents per annual burden per Total hours respondent responses response ---------------------------------------------------------------------------------------------------------------- Medicated feed reports, Sec. N/A 5 1 5 * 0.25 1.25 510.301(a) and (b)............... Mandatory adverse event reporting, 1932 22 81 1,782 1 1,782 21 U.S.C. 360b(l); Sec. 514.80(b)(1); (b)(2)(i) and (ii); (b)(3); and (b)(4)(iv)(A)........ Voluntary adverse event reporting 1932a 197 1 197 1 197 by veterinarians and the general public........................... Periodic drug experience reports, 2301 200 8.11 1,622 16 25,952 Sec. 514.80(b)(4).............. Special drug experience reports, 2301 200 0.57 114 2 228 Sec. 514.80(b)(5)(i)........... Submission of advertisements and 2301 200 20.12 4,024 2 8,048 promotional labeling, Sec. 514.80(b)(5)(ii)................. Submission of distributor 2301 190 0.1 19 2 38 statements, Sec. 514.80(b)(5)(iii)................ ----------------------------------------------------------------------------- Total......................... ........... ........... ........... ........... ........... 36,246.25 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. * (15 minutes). Table 2--Estimated Annual Recordkeeping Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of Total Average Activity Number of records per annual burden per Total hours recordkeepers recordkeeper records recordkeeping ---------------------------------------------------------------------------------------------------------------- Recordkeeping, Sec. 510.301 \2\......... 5 1 5 4 20 Recordkeeping, 21 U.S.C. 360b(l) and Sec. 646.70 7.19 4,649.8 14 65,097 514.80(e) \3\........................... --------------------------------------------------------------------- Total..................................... ............. ............ ........... ............. 65,117 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec. 510.301. \3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under Sec. 514.80(e). We base our reporting and recordkeeping estimates on our experience with adverse event reporting for approved new animal drugs and the number of reports received in the previous 3 years. Since the [[Page 5109]] consolidation of the 0910-0012 collection into this collection in 2004, we have included the estimated recordkeeping burden for medicated feed adverse event reports as part of our estimate of the recordkeeping burden of all mandatory adverse event reports for new animal drugs. To improve the clarity of our estimates we have added a row to table 2, on which we separately report our recordkeeping estimate for medicated feed adverse event reports (20 hours). The burden of this collection has changed. There was a slight increase in the estimated number of reports submitted to FDA under total annual responses (by 7.8 responses) and there was a slight overall decrease in burden hours (by 1.75 hours). This minor fluctuation in responses and hours is due to the normal variation in the submission of reports to FDA, the correction of mathematical errors, and a change in reporting methodology (addition of a new row to table 1 and table 2). We continually strive to improve our systems for collecting and analyzing drug experience reports and adverse event reports. To that end, we have developed an electronic submission system by which Form FDA 2301 may be submitted to the Agency. For Form FDA 1932a, we have a fillable electronic form available online, which can be submitted by email to FDA Center for Veterinary Medicine. We specifically invite comment from respondents on the utility of these reporting forms. Electronic adverse event reporting for approved new animal drugs (including mandatory reporting under Sec. 514.80(b) and voluntary reporting) has been approved under OMB control number 0910-0645. Reporting and recordkeeping associated with the index of legally marketed unapproved new animal drugs for minor species (21 CFR part 516) is approved under OMB control number 0910-0620. Dated: January 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02234 Filed 2-2-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices 5107
Based Preventive Controls for Food for 395–7285, or emailed to oira_ bearing or containing new animal drugs
Animals; Draft Guidance for Industry; submission@omb.eop.gov. All under section 512(m)(4).
Availability’’ that appeared in the comments should be identified with the Section 514.80 of our regulations (21
Federal Register of January 23, 2018. OMB control number 0910–0284. Also CFR 514.80) sets forth the recordkeeping
The document announced the include the FDA docket number found and reporting requirements for
availability of a draft guidance for in brackets in the heading of this applicants and nonapplicants of
industry #245 entitled ‘‘Hazard Analysis document. approved NADAs and ANADAs. Section
and Risk-Based Preventive Controls for FOR FURTHER INFORMATION CONTACT: Ila 510.301 of our regulations (21 CFR
Food for Animals.’’ The document was S. Mizrachi, Office of Operations, Food 510.301) sets forth the recordkeeping
published with the incorrect docket and Drug Administration, Three White and reporting requirements for licensed
number. This document corrects that Flint North, 10A–12M, 11601 medicated feed manufacturing facilities.
error. Landsdown St., North Bethesda, MD Recordkeeping and reporting
FOR FURTHER INFORMATION CONTACT: Lisa 20852, 301–796–7726, PRAStaff@ requirements for applicants of approved
Granger, Office of Policy and Planning, fda.hhs.gov. NADAs and ANADAs. Section 514.80
Food and Drug Administration, 10903 requires applicants to keep records of
SUPPLEMENTARY INFORMATION: In and report to us data, studies, and other
New Hampshire Ave., Bldg. 32, Rm. compliance with 44 U.S.C. 3507, FDA
3330, Silver Spring, MD 20993–0002, information concerning experience with
has submitted the following proposed new animal drugs for each approved
301–796–9115. collection of information to OMB for
SUPPLEMENTARY INFORMATION: In the NADA and ANADA. Following
review and clearance. complaints from animal owners or
Federal Register of Tuesday, January 23,
2018 (83 FR 3163), in FR Doc. 2018– Animal Drug Adverse Event Reporting veterinarians or following their own
01126, on page 3163, the following and Recordkeeping—21 U.S.C. 360b(l), detection of a problem, applicants are
correction is made: 21 CFR 510.301, and 514.80 required to submit adverse event reports
1. On page 3163, in the first column, and product defect reports under
OMB Control Number 0910–0284— § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3),
in the header of the document, the Extension
docket number is corrected to read and (b)(4)(iv)(A) on Form FDA 1932.
‘‘FDA–2018–D–0388’’. With regard to adverse events and Form FDA 1932a (the voluntary
product/manufacturing defects reporting form) is used by veterinarians
Dated: January 30, 2018. associated with approved new animal and the general public to submit adverse
Leslie Kux, drugs, section 512(l) of the Federal event reports, product defects, and lack
Associate Commissioner for Policy. Food, Drug, and Cosmetic Act (FD&C of effectiveness complaints directly to
[FR Doc. 2018–02181 Filed 2–2–18; 8:45 am] Act) (21 U.S.C. 360b(l)) requires FDA. Form FDA 2301 is used by
BILLING CODE 4164–01–P applicants with approved new animal applicants to submit the required
drug applications (NADAs) and transmittal of periodic reports
abbreviated new animal drug (§ 514.80(b)(4)); special drug experience
DEPARTMENT OF HEALTH AND applications (ANADAs) to establish and reports (§ 514.80(b)(5)(i)); promotional
HUMAN SERVICES maintain records and reports of data material for new animal drugs
relating to experience with uses of such (§ 514.80(b)(5)(ii)); and distributor
Food and Drug Administration drug, or with respect to animal feeds statements (§ 514.80(b)(5)(iii)). We
[Docket No. FDA–2017–N–2428] bearing or containing such drug, to review the records and reports required
facilitate a determination under section in § 514.80 and the voluntary reports to
Agency Information Collection 512(e) as to whether there may be facilitate a determination under section
Activities; Submission for Office of grounds for suspending or withdrawing 512(e) of the FD&C Act as to whether
Management and Budget Review; approval of the NADA or ANADA under there may be grounds for suspending or
Comment Request; Animal Drug section 512(e) or 512(m)(4). Sections withdrawing approval of the new
Adverse Event Reporting and 571(e)(3) and 512(e)(2) of the FD&C Act animal drug. We have made minor
Recordkeeping (21 U.S.C. 360ccc(e)(3) and 360b(e)(2)) editorial revisions to Form FDA 1932a
require that applicants with to clarify how to report adverse drug
AGENCY: Food and Drug Administration,
conditionally approved new animal events associated with compounded
HHS.
drug applications (CNADAs) maintain products using that form. Submitters are
ACTION: Notice. adequate records and make reports in already reporting adverse drug events
SUMMARY: The Food and Drug accordance with a regulation or order associated with compounded products
Administration (FDA or we) is issued under section 512(l). Finally, on Form FDA 1932a. The clarifications
announcing that a proposed collection section 512(m)(5) of the FD&C Act include: the addition of a new question,
of information has been submitted to the requires an applicant for a license to ‘‘Is this a compounded product?’’; the
Office of Management and Budget manufacture animal feeds bearing or addition of a new field to allow the
(OMB) for review and clearance under containing new animal drugs to submitter to provide product strength,
the Paperwork Reduction Act of 1995. maintain adequate records and make ‘‘Strength of Active Ingredient(s)’’;
reports ‘‘as the Secretary may by general modifying the title of the existing field
DATES: Fax written comments on the
regulation, or by order with respect to requesting the name of manufacturer, so
collection of information by March 7, such application, prescribe on the basis that it reads, ‘‘Name of Manufacturer or
sradovich on DSK3GMQ082PROD with NOTICES
2018. of a finding that such records and Compounding Pharmacy/Compounder
ADDRESSES: To ensure that comments on reports are necessary in order to enable of Suspected Product’’; and a request for
the information collection are received, the Secretary to determine’’ whether contact information for the
OMB recommends that written there may be grounds for suspending or manufacturer or compounder. We
comments be faxed to the Office of withdrawing approval of the new estimate that the revisions will not
Information and Regulatory Affairs, animal drug under section 512(e) or a change the average amount of time
OMB, Attn: FDA Desk Officer, Fax: 202– license to manufacture animal feeds necessary to complete the form.
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consolidation of the 0910–0012 DEPARTMENT OF HEALTH AND is composed of 11 members appointed
collection into this collection in 2004, HUMAN SERVICES by the Comptroller General.
we have included the estimated II. Agenda. At each scheduled
recordkeeping burden for medicated Meetings Announcement for the meeting, the Committee will hear
feed adverse event reports as part of our Physician-Focused Payment Model presentations on PFPMs that are ready
estimate of the recordkeeping burden of Technical Advisory Committee for Committee deliberation. The
all mandatory adverse event reports for Required by the Medicare Access and presentations will be followed by public
new animal drugs. To improve the CHIP Reauthorization Act of 2015 comment and Committee deliberation. If
clarity of our estimates we have added (MACRA) the Committee completes deliberations,
a row to table 2, on which we separately voting will occur on recommendations
ACTION: Notice of public meetings. to the Secretary of Health and Human
report our recordkeeping estimate for
SUMMARY: This notice announces the Services. There will be time allocated
medicated feed adverse event reports
2018 meetings of the Physician-Focused for public comment on agenda items.
(20 hours). Documents will be posted on the
Payment Model Technical Advisory
The burden of this collection has Committee website and distributed on
Committee (hereafter referred to as ‘‘the
changed. There was a slight increase in the Committee listserv prior to the
Committee’’) which will be held in
the estimated number of reports public meeting. The agenda is subject to
Washington, DC. This meeting will
submitted to FDA under total annual include voting and deliberations on change. If the agenda does change, we
responses (by 7.8 responses) and there proposals for physician-focused will inform registrants and update the
was a slight overall decrease in burden payment models (PFPMs) submitted by website.
hours (by 1.75 hours). This minor III. Meeting Attendance. These
members of the public. All meetings are
fluctuation in responses and hours is meetings are open to the public. The
open to the public.
due to the normal variation in the public may also attend via conference
DATES: The 2018 PTAC meetings will call or view the meeting via livestream
submission of reports to FDA, the occur on the following dates:
correction of mathematical errors, and a at www.hhs.gov/live. The conference
• Monday–Tuesday, March 26–27, call dial-in information will be sent to
change in reporting methodology 2018, from 9:00 a.m. to 5:00 p.m. ET
(addition of a new row to table 1 and registrants prior to the meeting.
• Thursday–Friday, June 14–15, 2018, Meeting Registration: The public may
table 2). from 9:00 a.m. to 5:00 p.m. ET attend the meetings in-person,
We continually strive to improve our • Thursday–Friday, September 6–7, participate by phone via audio
systems for collecting and analyzing 2018, from 9:00 a.m. to 5:00 p.m. ET teleconference, or view the meeting via
drug experience reports and adverse • Monday–Tuesday, December 10–11, livestream. Space is limited and
event reports. To that end, we have 2018, from 9:00 a.m. to 5:00 p.m. ET registration is preferred in order to
developed an electronic submission Please note that times are subject to attend in-person or by phone.
system by which Form FDA 2301 may change. If the times change, registrants Registration may be completed online at
be submitted to the Agency. For Form will be notified directly via email. www.regonline.com/PTACMeetings
FDA 1932a, we have a fillable electronic ADDRESSES: All PTAC meetings will be Registration.
form available online, which can be held in the Great Hall of the Hubert H. The following information is
submitted by email to FDA Center for Humphrey Building, 200 Independence submitted when registering:
Veterinary Medicine. We specifically Avenue SW, Washington, DC 20201. Name:
Company/organization name:
invite comment from respondents on FOR FURTHER INFORMATION CONTACT: Ann
Postal address:
the utility of these reporting forms. Page, Designated Federal Official, at the Email address:
Electronic adverse event reporting for Office of Health Policy, Assistant A confirmation email will be sent to
approved new animal drugs (including Secretary for Planning and Evaluation registrants shortly after completing the
mandatory reporting under § 514.80(b) (ASPE), U.S. Department of Health and registration process.
and voluntary reporting) has been Human Services, 200 Independence IV. Special Accommodations. If sign
approved under OMB control number Ave. SW, Washington, DC 20201, (202) language interpretation or other
0910–0645. Reporting and 690–6870. reasonable accommodation for a
recordkeeping associated with the index SUPPLEMENTARY INFORMATION: disability is needed, please contact
of legally marketed unapproved new I. Purpose. The Physician-Focused Angela Tejeda, no later than one week
animal drugs for minor species (21 CFR Payment Model Technical Advisory prior to the scheduled meeting. Please
part 516) is approved under OMB Committee (‘‘the Committee’’) is submit your requests by email to
control number 0910–0620. required by the Medicare Access and Angela.Tejeda@hhs.gov or by calling
CHIP Reauthorization Act of 2015, 42 202–401–8297.
Dated: January 30, 2018. U.S.C. 1395ee. This Committee is also V. Copies of the PTAC Charter and
Leslie Kux, governed by provisions of the Federal Meeting Material. The Secretary’s
Associate Commissioner for Policy. Advisory Committee Act, as amended (5 Charter for the Physician-Focused
[FR Doc. 2018–02234 Filed 2–2–18; 8:45 am] U.S.C. App.), which sets forth standards Payment Model Technical Advisory
BILLING CODE 4164–01–P
for the formation and use of federal Committee is available on the ASPE
advisory committees. In accordance website at https://aspe.hhs.gov/charter-
with its statutory mandate, the
sradovich on DSK3GMQ082PROD with NOTICES
physician-focused-payment-model-
Committee is to review physician- technical-advisory-committee.
focused payment model proposals and Additional material for this meeting
prepare recommendations regarding can be found on the ASPE PTAC
whether such models meet criteria that website. For updates and
were established through rulemaking by announcements, please use the link to
the Secretary of Health and Human subscribe to the ASPE PTAC email
Services (the Secretary). The Committee listserv.
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Document Created: 2018-02-03 01:24:57
Document Modified: 2018-02-03 01:24:57
| 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 | Fax written comments on the collection of information by March 7, 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 5107 |
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