81 FR 12908 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 48 (March 11, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 48 (March 11, 2016)
| Page Range | 12908-12910 | |
| FR Document | 2016-05491 |
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)] [Notices] [Pages 12908-12910] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05491] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-0268] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) 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 April 11, 2016. 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-New and title ``Individual Patient Expanded Access Applications: Form FDA 3926.'' Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926--OMB Control Number 0910--NEW I. Background In the Federal Register of February 10, 2015 (80 FR 7318), FDA announced the availability of a draft guidance for industry entitled ``Individual Patient Expanded Access Applications: Form FDA 3926.'' In the draft guidance, FDA provided draft Form FDA 3926 (Individual Patient Expanded Access--Investigational New Drug Application (IND)) at Appendix 1 and described this draft form, which FDA stated it intended to make available for licensed physicians to use for expanded access requests for individual patient INDs as an alternative to Form FDA 1571 (Investigational New Drug Application (IND)). As described in the final guidance, Form FDA 3926 provides a streamlined means to request expanded access to an investigational drug outside of a clinical investigation, or to an approved drug where availability is limited by a risk evaluation and mitigation strategy (REMS), for 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. Form FDA 3926 may also be used for certain followup submissions to an individual patient expanded access IND. FDA may permit expanded access to an investigational new drug outside of a clinical investigation, or to an approved drug where availability is limited by a REMS, for an individual patient when the 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. 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. Section 312.305(b) sets forth the submission requirements for all types of expanded access requests. 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 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 patient. Form FDA 1571 is currently used by sponsors for all types of IND submissions to meet the requirements in Sec. 312.23(a). FDA intends to accept submission of a completed Form FDA 3926 to comply with the IND submission requirements in Sec. Sec. 312.23, 312.305(b), and 312.310(b). FDA intends to consider 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, the following information would be submitted to FDA by those using Form FDA 3926:Initials for the patient and date of submission. Type of submission (initial or followup 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 [[Page 12909]] 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. Alter na tively, 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 followup/additional submissions), including the type of submission being made. FDA intends to accept Form FDA 3926 for certain followup/additional submissions, which include the following: Initial Written IND Safety Report (Sec. 312.32(c)); Follow-up 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. In the Federal Register of February 10, 2015 (80 FR 7318), FDA published a 60-day notice requesting public comment on the proposed collection of information. Twelve comments were received. However, FDA received no comments concerning the accuracy of FDA's estimate of the burden of the proposed collection of information. FDA received several comments on ways to enhance the quality, utility, and clarity of FDA Form 3926 through, for example, the addition of instructions for completing the form and use of the form for certain followup submissions. (Comment 1) Five comments requested instructions, clarification, or directions concerning the use and submission of Form FDA 3926. (Response) FDA updated instructions based on information originally included in the draft guidance that will be provided in conjunction with final Form FDA 3926. Clarifying language on form fields has been added to the instructions and the guidance. (Comment 2) One comment asked for clarification regarding Field 1 of Form FDA 3926 to indicate that the requesting physician should provide this information (not the patient). (Response) Clarification on Field 1 has been added to the form instructions to state that the patient need not initial the form. This is to indicate that the requesting physician should enter the patient's initials. (Comment 3) One comment stated that the information requested in Field 3 of draft Form FDA 3926 could become lengthy to complete and asked if a PDF could be attached to the form to provide this information. (Response) This information is now requested in Field 5. Field 5 has been enlarged to accommodate more handwritten information. The space also has been updated to allow expansion when information is entered electronically in the fillable PDF. Clarifying language has been added to the form and instructions. (Comment 4) Three comments requested electronic submission capability to expedite applications. (Response) FDA is determining whether electronic submissions are feasible. FDA intends to provide additional information via its Web site should this become an option. (Comment 5) Several comments concerned the use of FDA Form 3926 for followup submissions. One comment suggested that FDA develop a new form for followup submissions (rather than requiring the use of Form FDA 1571). Three comments asked that instructions be developed for ongoing patient reporting (i.e., followup submissions). (Response) FDA has revised the guidance, instructions, and Form FDA 3926 so that the form may be used instead of Form FDA 1571 for certain followup submissions to an existing single patient expanded access IND. Form FDA 3926, the instructions, and the guidance identify the types of followup submissions that qualify and provide additional information on how to use Form FDA 3926 for such submissions. II. Burden Estimate As discussed previously in this document, Form FDA 3926 will be available for licensed physicians to use as a streamlined means to request expanded access to an investigational drug outside of a clinical investigation, or to an approved drug where availability is limited by a REMS, for 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, and to submit certain followup reports. 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, 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 patient. Form FDA 1571 is currently used by sponsors for all types of IND submissions. However, FDA is concerned that physicians requesting expanded access for an individual patient may have encountered difficulty in completing Form FDA 1571 and the associated documents because the form is not tailored to requests for individual patient expanded access. The submission requirements for all types of expanded access requests for investigational drugs are provided under Sec. 312.305(b) of FDA's expanded access regulations. Additional submission requirements for individual [[Page 12910]] patient expanded access requests are provided under Sec. 312.310(b), and the requirements for requesting individual patient expanded access for emergency use are provided under Sec. 312.310(d). FDA currently has OMB approval under control number 0910-0014 for individual patient expanded access information collection under Sec. Sec. 312.305(b), 312.310(b), and 312.310(d). The submission requirements concerning the use of Form FDA 3926 for certain followup reports are provided under Sec. Sec. 312.32(c), 312.32(d), 312.33, 312.310(c)(2), 312.30, 312.41, and 312.42(e). The estimates for ``number of respondents,'' ``number of responses per respondent,'' and ``total annual responses'' were obtained from the Center for Drug Evaluation and Research (CDER) reports and data management systems 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 provided by CDER and other Department of Health and Human Services personnel who are familiar with preparing and reviewing expanded access submissions by practicing physicians. Based on data for the number of submissions to FDA during 2011, 2012, and 2013, we originally estimated that approximately 790 licensed physicians would use Form 3926 to submit 1.46 requests per physician (respondent) for individual patient expanded access, for a total of 1,153 responses annually. In response to comments received, FDA clarifies in the final guidance and in the form instructions that licensed physicians may also use Form FDA 3926 for certain followup submissions. Based on data for the number of followup submissions during 2011, 2012, and 2013, FDA estimates that about 790 physicians will each use Form FDA 3926 to submit 1.57 followup submissions per physician, for approximately 1,241 followup 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 followup 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. Under OMB control number 0910-0014, FDA currently has OMB approval of 17,592 hours for these submissions. The use of FDA Form 3926 will reduce the current burden by 15,797 hours. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden 1 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Guidance on individual patient expanded access Number of responses per Total annual Average burden per response Total hours applications: Form FDA 3926 respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Expanded access submission for treatment of an 790 3.03 2,394 0.75 (45 minutes)................. 1,795 individual patient, including submission of Form FDA 3926. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05491 Filed 3-10-16; 8:45 am] BILLING CODE 4164-01-P
![12908 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
acrylamide. The guidance is intended to Spring, MD 20993–0002, PRAStaff@ (LOA) from the existing IND holder that
suggest a range of possible approaches fda.hhs.gov. permits FDA to reference that IND.
to reducing acrylamide levels and not to Section 312.305(b) sets forth the
SUPPLEMENTARY INFORMATION: In submission requirements for all types of
identify specific recommended
compliance with 44 U.S.C. 3507, FDA expanded access requests. One of the
approaches.
has submitted the following proposed requirements under § 312.305(b)(2) is
II. Electronic Access collection of information to OMB for that a ‘‘cover sheet’’ must be included
Persons with access to the Internet review and clearance. ‘‘meeting the requirements of
may obtain the guidance at either Guidance for Industry on Individual § 312.23(a).’’ This provision applies to
http://www.fda.gov/FoodGuidances or Patient Expanded Access Applications: several types of submissions under 21
http://www.regulations.gov. Use the Form FDA 3926—OMB Control Number CFR part 312, ranging from commercial
FDA Web site listed in the previous 0910—NEW INDs under § 312.23 that involve large
sentence to find the most current groups of patients enrolled in clinical
version of the guidance. I. Background trials to requests from physicians to use
Dated: March 1, 2016. In the Federal Register of February an investigational drug for an individual
Leslie Kux, 10, 2015 (80 FR 7318), FDA announced patient. Form FDA 1571 is currently
the availability of a draft guidance for used by sponsors for all types of IND
Associate Commissioner for Policy.
industry entitled ‘‘Individual Patient submissions to meet the requirements in
[FR Doc. 2016–05490 Filed 3–10–16; 8:45 am]
Expanded Access Applications: Form § 312.23(a). FDA intends to accept
BILLING CODE 4164–01–P submission of a completed Form FDA
FDA 3926.’’ In the draft guidance, FDA
provided draft Form FDA 3926 3926 to comply with the IND
(Individual Patient Expanded Access— submission requirements in §§ 312.23,
DEPARTMENT OF HEALTH AND 312.305(b), and 312.310(b). FDA intends
HUMAN SERVICES Investigational New Drug Application
(IND)) at Appendix 1 and described this to consider a completed Form FDA 3926
Food and Drug Administration draft form, which FDA stated it with the box in Field 10 checked and
intended to make available for licensed the form signed by the physician to be
[Docket No. FDA–2015–D–0268] a request in accordance with § 312.10
physicians to use for expanded access
requests for individual patient INDs as for a waiver of any additional
Agency Information Collection requirements in part 312 for an IND
Activities; Submission for Office of an alternative to Form FDA 1571
(Investigational New Drug Application submission, including additional
Management and Budget Review; information currently provided in Form
Comment Request; Guidance for (IND)).
FDA 1571 and Form FDA 1572
Industry on Individual Patient As described in the final guidance,
(Statement of Investigator, which
Expanded Access Applications: Form Form FDA 3926 provides a streamlined
provides the identity and qualifications
FDA 3926 means to request expanded access to an
of the investigator conducting the
investigational drug outside of a clinical
AGENCY: Food and Drug Administration, clinical investigation).
investigation, or to an approved drug Under § 312.310(d), in an emergency
HHS. where availability is limited by a risk situation that requires the patient to be
ACTION: Notice. evaluation and mitigation strategy treated before a written submission can
(REMS), for an individual patient who be made, the request to use the
SUMMARY: The Food and Drug
has a serious or immediately life- investigational drug for individual
Administration (FDA) is announcing
threatening disease or condition and patient expanded access may be made
that a proposed collection of
there is no comparable or satisfactory by telephone (or other rapid means of
information has been submitted to the
alternative therapy to diagnose, monitor, communication) to the appropriate FDA
Office of Management and Budget
or treat the disease or condition. Form review division. Authorization of the
(OMB) for review and clearance under
FDA 3926 may also be used for certain emergency use may be given by an FDA
the Paperwork Reduction Act of 1995.
followup submissions to an individual official over the telephone, provided the
DATES: Fax written comments on the patient expanded access IND.
collection of information by April 11, physician explains how the expanded
FDA may permit expanded access to access use will meet the requirements of
2016. an investigational new drug outside of §§ 312.305 and 312.310 and agrees to
ADDRESSES: To ensure that comments on a clinical investigation, or to an submit an expanded access application
the information collection are received, approved drug where availability is within 15 working days of FDA’s initial
OMB recommends that written limited by a REMS, for an individual authorization of the expanded access
comments be faxed to the Office of patient when the applicable criteria in use (§ 312.310(d)). The physician may
Information and Regulatory Affairs, § 312.305(a) (21 CFR 312.305(a)) (which choose to use Form FDA 3926 for the
OMB, Attn: FDA Desk Officer, FAX: apply to all types of expanded access) expanded access application.
202–395–7285, or emailed to oira_ and the criteria in § 312.310(a) (21 CFR As explained in the instructions for
submission@omb.eop.gov. All 312.310(a)) (which apply specifically to Form FDA 3926, the following
comments should be identified with the individual patient expanded access, information would be submitted to FDA
OMB control number 0910–New and including for emergency use) are met. by those using Form FDA 3926:
title ‘‘Individual Patient Expanded The physician may satisfy some of the • Initials for the patient and date of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Access Applications: Form FDA 3926.’’ submission requirements by referring to submission.
Also include the FDA docket number information in an existing IND, • Type of submission (initial or
found in brackets in the heading of this ordinarily the one held by the followup submission).
document. investigational drug’s manufacturer, if • Clinical information, including
FOR FURTHER INFORMATION CONTACT: FDA the physician obtains permission from indication, brief clinical history of the
PRA Staff, Office of Operations, Food that IND holder. If permission is patient (age, gender, weight, allergies,
and Drug Administration, 8455 obtained, the physician should then diagnosis, prior therapy, response to
Colesville Rd., COLE–14526, Silver provide to FDA a letter of authorization prior therapy), and the reason for
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![12910 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
patient expanded access requests are received for individual patient followup submissions during 2011,
provided under § 312.310(b), and the expanded access use under part 312. 2012, and 2013, FDA estimates that
requirements for requesting individual The estimates for ‘‘average burden per about 790 physicians will each use
patient expanded access for emergency response’’ were based on information Form FDA 3926 to submit 1.57 followup
use are provided under § 312.310(d). provided by CDER and other submissions per physician, for
FDA currently has OMB approval under Department of Health and Human approximately 1,241 followup responses
control number 0910–0014 for Services personnel who are familiar annually. Based on these estimates, FDA
individual patient expanded access with preparing and reviewing expanded calculates the total annual responses to
information collection under access submissions by practicing be 2,394 (1,153 requests for individual
§§ 312.305(b), 312.310(b), and physicians. patient expanded access and 1,241
312.310(d). The submission Based on data for the number of followup submissions) by 790
requirements concerning the use of submissions to FDA during 2011, 2012, physicians for an average of 3.03
Form FDA 3926 for certain followup and 2013, we originally estimated that responses per respondent. FDA
reports are provided under §§ 312.32(c), approximately 790 licensed physicians estimates the average burden per
312.32(d), 312.33, 312.310(c)(2), 312.30, would use Form 3926 to submit 1.46 response to be 45 minutes (0.75 hour).
312.41, and 312.42(e). requests per physician (respondent) for Based on this estimate, FDA calculates
The estimates for ‘‘number of individual patient expanded access, for the total burden to be 1,795 hours.
respondents,’’ ‘‘number of responses per a total of 1,153 responses annually. In Under OMB control number 0910–0014,
respondent,’’ and ‘‘total annual response to comments received, FDA FDA currently has OMB approval of
responses’’ were obtained from the clarifies in the final guidance and in the 17,592 hours for these submissions. The
Center for Drug Evaluation and Research form instructions that licensed use of FDA Form 3926 will reduce the
(CDER) reports and data management physicians may also use Form FDA current burden by 15,797 hours.
systems and from other sources familiar 3926 for certain followup submissions. FDA estimates the burden of this
with the number of submissions Based on data for the number of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Guidance on individual patient expanded access Number of Total annual
responses per burden per Total hours
applications: Form FDA 3926 respondents responses
respondent response
Expanded access submission for treatment of an indi- 790 3.03 2,394 0.75 (45 min- 1,795
vidual patient, including submission of Form FDA 3926. utes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 8, 2016. including each proposed extension of an www.regulations.gov will be posted to
Leslie Kux, existing collection of information, and the docket unchanged. Because your
Associate Commissioner for Policy. to allow 60 days for public comment in comment will be made public, you are
[FR Doc. 2016–05491 Filed 3–10–16; 8:45 am] response to the notice. This notice solely responsible for ensuring that your
BILLING CODE 4164–01–P
invites comments on the information comment does not include any
collection provisions of the regulation confidential information that you or a
requiring the manufacturer, packer, or third party may not wish to be posted,
DEPARTMENT OF HEALTH AND distributor of a dietary supplement to such as medical information, your or
HUMAN SERVICES notify us that it is marketing a dietary anyone else’s Social Security number, or
supplement product that bears on its confidential business information, such
Food and Drug Administration label or in its labeling a statement as a manufacturing process. Please note
provided for in the Federal Food, Drug, that if you include your name, contact
[Docket No. FDA–2009–N–0221] and Cosmetic Act (the FD&C Act). The information, or other information that
notice also invites comment on a new identifies you in the body of your
Agency Information Collection
electronic form that allows comments, that information will be
Activities; Proposed Collection;
manufacturers, packers, and distributors posted on http://www.regulations.gov.
Comment Request; Food Labeling;
of dietary supplements to notify us via • If you want to submit a comment
Notification Procedures for Statements
FDA’s Unified Registration and Listing with confidential information that you
on Dietary Supplements
System (FURLS). do not wish to be made available to the
AGENCY: Food and Drug Administration, DATES: Submit either electronic or public, submit the comment as a
HHS. written comments on the collection of written/paper submission and in the
ACTION: Notice. information by May 10, 2016. manner detailed (see ‘‘Written/Paper
ADDRESSES: You may submit comments Submissions’’ and ‘‘Instructions’’).
SUMMARY: The Food and Drug as follows:
Administration (FDA or we) is Written/Paper Submissions
asabaliauskas on DSK3SPTVN1PROD with NOTICES
announcing an opportunity for public Electronic Submissions
comment on the proposed collection of Submit electronic comments in the Submit written/paper submissions as
certain information by the Agency. following way: follows:
Under the Paperwork Reduction Act of • Federal eRulemaking Portal: http:// • Mail/Hand delivery/Courier (for
1995 (the PRA), Federal Agencies are www.regulations.gov. Follow the written/paper submissions): Division of
required to publish notice in the instructions for submitting comments. Dockets Management (HFA–305), Food
Federal Register concerning each Comments submitted electronically, and Drug Administration, 5630 Fishers
proposed collection of information, including attachments, to http:// Lane, Rm. 1061, Rockville, MD 20852.
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Document Created: 2016-03-11 01:51:23
Document Modified: 2016-03-11 01:51:23
| 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 April 11, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 12908 |
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