Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11449 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses Average burden per response Total hours 

610.47(a)(3) ...................................... 1,945 12 .03 23,400 0.17 (10 minutes) ............................. 3,978 

610.47(b)(3) ...................................... 4,961 0 .41 2,050 1 ....................................................... 2,050 

630.6(a) 3 ........................................... 648 668 .72 433,333 0.08 (5 minutes) ............................... 34,667 

630.6(a) 4 ........................................... 84 53 .57 4,500 1.5 (90 minutes) ............................... 6,750 

630.6(d)(1) ........................................ 63 35 .71 2,250 1 ....................................................... 2,250 

Total ........................................... ........................ ........................ ........................ ........................................................... 61,043 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 

4,961 + 2,361 = 366). 3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 

4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. 

Dated: February 25, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04381 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1721] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Investigational 

New Drug Applications 

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 2, 

2015. 

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 oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0014. 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, PRAStaff@

fda.hhs.gov. 

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. 

Investigational New Drug (IND) 

Regulations—21 CFR Part 312 (OMB 

Control Number 0910–0014)—Extension 

FDA is requesting OMB approval for 

the reporting and recordkeeping 

requirements contained in FDA 

regulations entitled ‘‘Investigational 

New Drug Application’’ in part 312 (21 

CFR part 312). Part 312 implements 

provisions of section 505(i) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355(i)) to 

issue regulations under which the 

clinical investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products can be 

conducted. 

FDA is charged with implementing 

statutory requirements that drug 

products marketed in the United States 

be shown to be safe and effective, 

properly manufactured, and properly 

labeled for their intended uses. Section 

505(a) of the FD&C Act provides that a 

new drug may not be introduced or 

delivered for introduction into interstate 

commerce in the United States unless 

FDA has previously approved a new 

drug application (NDA). FDA approves 

an NDA only if the sponsor of the 

application first demonstrates that the 

drug is safe and effective for the 

conditions prescribed, recommended, or 

suggested in the product’s labeling. 

Proof must consist, in part, of adequate 

and well-controlled studies, including 

studies in humans, that are conducted 

by qualified experts. The IND 

regulations establish reporting 

requirements that include an initial 

application as well as amendments to 

that application, reports on significant 

revisions of clinical investigation plans, 

and information on a drug’s safety or 

effectiveness. In addition, the sponsor is 

required to give FDA an annual 

summary of the previous year’s clinical 

experience. 

Submissions are reviewed by medical 

officers and other Agency scientific 

reviewers assigned responsibility for 

overseeing the specific study. The IND 

regulations also contain recordkeeping 

requirements that pertain to the 

responsibilities of sponsors and 

investigators. The detail and complexity 

of these requirements are dictated by the 

scientific procedures and human subject 

safeguards that must be followed in the 

clinical tests of investigational new 

drugs. 

The IND information collection 

requirements provide the means by 

which FDA can monitor the clinical 

investigation of the safety and 

effectiveness of unapproved new drugs 

and biological products, including the 

following: (1) Monitor the safety of 

ongoing clinical investigations; (2) 

determine whether the clinical testing of 

a drug should be authorized; (3) ensure 

production of reliable data on the 

metabolism and pharmacological action 

of the drug in humans; (4) obtain timely 

information on adverse reactions to the 

drug; (5) obtain information on side 

effects associated with increasing doses; 

(6) obtain information on the drug’s 

effectiveness; (7) ensure the design of 

well-controlled, scientifically valid 

studies; and (8) obtain other information 

pertinent to determining whether 

clinical testing should be continued, 

and information related to the 

protection of human subjects. Without 

the information provided by industry as 

required under the IND regulations, 

FDA cannot authorize or monitor the 

clinical investigations which must be 

conducted prior to authorizing the sale 

and general use of new drugs. These 

reports enable FDA to monitor a study’s 

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11450 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

progress, to assure subject safety, to 

assure that a study will be conducted 

ethically, and to increase the likelihood 

that the sponsor will conduct studies 

that will be useful in determining 

whether the drug should be marketed 

and available for use in medical 

practice. 

There are two forms that are required 

under part 312: 

Form FDA–1571—‘‘Investigational 

New Drug Application.’’ A person who 

intends to conduct a clinical 

investigation submits this form to FDA. 

It includes the following information: 

(1) A cover sheet containing 

background information on the sponsor 

and investigator; 

(2) A table of contents; 

(3) An introductory statement and 

general investigational plan; 

(4) An investigator’s brochure 

describing the drug substance; 

(5) A protocol for each planned study; 

(6) Chemistry, manufacturing, and 

control information for each 

investigation; 

(7) Pharmacology and toxicology 

information for each investigation; and 

(8) Previous human experience with 

the investigational drug. 

Form FDA–1572—‘‘Investigator 

Statement.’’ Before permitting an 

investigator to begin participation in an 

investigation, the sponsor must obtain 

and record this form. It includes 

background information on the 

investigator and the investigation, and a 

general outline of the planned 

investigation and the study protocol. 

FDA is requesting OMB approval for 

the following reporting and 

recordkeeping requirements in part 312. 

I. Reporting Requirements 

Section 312.2(e)—Requests for FDA 

advice on the applicability of part 

312 to a planned clinical 

investigation. 

Section 312.6—Labeling of an 

investigational new drug. Estimates 

for the information collection in 

this requirement are included under 

§ 312.23(a)(7)(iv)(d). 

Section 312.8—Charging for 

investigational drugs under an IND. 

Section 312.10—Applications for waiver 

of requirements under part 312. As 

indicated in § 312.10(a), estimates 

for the information collection in 

this requirement are included under 

§§ 312.23 and 312.31. In addition, 

other waiver requests under 

§ 312.10 are estimated in table 1. 

Section 312.20(c)—Applications for 

investigations involving an 

exception from informed consent 

under § 50.24 (21 CFR 50.24). 

Estimates for the information 

collection in this requirement are 

included under § 312.23. 

Section 312.23—IND (content and 

format). 

Section 312.23(a)(1)—Cover sheet FDA– 

1571. 

Section 312.23(a)(2)—Table of Contents. 

Section 312.23(a)(3)—Investigational 

plan for each planned study. 

Section 312.23(a)(5)—Investigator’s 

brochure. 

Section 312.23(a)(6)—Protocols—Phase 

1, 2, and 3. 

Section 312.23(a)(7)—Chemistry, 

manufacturing, and control 

information. 

Section 312.23(a)(7)(iv)(a),(b),(c)—A 

description of the drug substance, a 

list of all components, and any 

placebo used. 

Section 312.23(a)(7)(iv)(d)—Labeling: 

Copies of labels and labeling to be 

provided each investigator. 

Section 312.23(a)(7)(iv)(e)— 

Environmental impact analysis 

regarding drug manufacturing and 

use. 

Section 312.23(a)(8)—Pharmacological 

and toxicology information. 

Section 312.23(a)(9)—Previous human 

experience with the investigational 

drug. 

Section 312.23(a)(10)—Additional 

information. 

Section 312.23(a)(11)—Relevant 

information. 

Section 312.23(f)—Identification of 

exception from informed consent. 

Section 312.30—Protocol amendments. 

§ 312.30(a)—New protocol 

§ 312.30(b)—Changes in protocol 

§ 312.30(c)—New investigator. 

§ 312.30(d)—Content and format. 

§ 312.30(e)—Frequency. 

Section 312.31—Information 

amendments. 

§ 312.31(b)—Content and format. 

— Chemistry, toxicology, or technical 

information. 

Section 312.32—Safety reports. 

§ 312.32(c)(1)—Written reports to 

FDA and to investigators. 

§ 312.32(c)(2)—Telephone reports to 

FDA for fatal or life-threatening 

experience. 

§ 312.32(c)(3)—Format or frequency. 

§ 312.32(d)—Followup submissions. 

Section 312.33—Annual reports. 

§ 312.33(a)—Individual study 

information. 

§ 312.33(b)—Summary information. 

§ 312.33(b)(1)—Adverse experiences. 

§ 312.33(b)(2)—Safety report 

summary. 

§ 312.33(b)(3)—List of fatalities and 

causes of death. 

§ 312.33(b)(4)—List of discontinuing 

subjects. 

§ 312.33 (b)(5)—Drug action. 

§ 312.33 (b)(6)—Preclinical studies 

and findings. 

§ 312.33 (b)(7)—Significant changes. 

§ 312.33(c)—Next year general 

investigational plan. 

§ 312.33(d)—Brochure revision. 

§ 312.33(e)—Phase I protocol 

modifications. 

§ 312.33(f)—Foreign marketing 

developments. 

Section 312.38(b) and (c)—Notification 

of withdrawal of an IND. 

Section 312.41—Comment and advice 

on an IND. Estimates for the 

information collection in this 

requirement are included under 

§ 312.23. 

Section 312.42—Sponsor requests that a 

clinical hold be removed, and 

submits a complete response to the 

issues identified in the clinical hold 

order. 

Section 312.44(c) and (d)—Opportunity 

for sponsor response to FDA when 

IND is terminated. 

Section 312.45(a) and (b)—Sponsor 

request for, or response to, an 

inactive status determination of an 

IND. 

Section 312.47—Meetings, including 

‘‘End-of-Phase 2’’ meetings and 

‘‘Pre-NDA’’ meetings. 

Section 312.48—Dispute resolution. 

Estimates for the information 

collection in this requirement are 

included under § 312.47. 

Section 312.53(c)—Investigator 

information. Investigator report 

(Form FDA–1572) and narrative; 

Investigator’s background 

information; Phase 1 outline of 

planned investigation and Phase 2 

outline of study protocol. 

Section 312.54(a) and (b)—Sponsor 

submissions concerning 

investigations involving an 

exception from informed consent 

under § 50.24. 

§ 312.55(b)—Sponsor reports to 

investigators on new observations, 

especially adverse reactions and 

safe use. Only ‘‘new observations’’ 

are estimated under this section; 

investigator brochures are included 

under § 312.23. 

Section 312.56(b), (c), and (d)—Sponsor 

monitoring of all clinical 

investigations, investigators, and 

drug safety; notification to FDA and 

others. 

Section 312.58(a)—Sponsor’s 

submission of records to FDA on 

request. 

Section 312.64—Investigator reports to 

the sponsor. 

§ 312.64(a)—Progress reports. 

§ 312.64(b)—Safety reports 

§ 312.64(c)—Final reports. 

§ 312.64(d)—Financial disclosure 

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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11451 

reports. 

Section 312.66—Investigator reports to 

institutional review board (IRB). 

Estimates for the information 

collection in this requirement are 

included under § 312.53. 

Section 312.70—Investigator 

disqualification; opportunity to 

respond to FDA. 

Section 312.83—Sponsor submission of 

treatment protocol. Estimates for 

this requirement are included under 

§ 312.320. 

Section 312.85—Sponsors conducting 

phase 4 studies. Estimates for the 

information collection in this 

requirement are included under 

§ 312.23, and under §§ 314.50, 

314.70, and 314.81 in OMB control 

number 0910–0001. 

Section 312.110(b)—Requests to export 

an investigational drug. 

Section 312.120—Submissions related 

to foreign clinical studies not 

conducted under an IND. 

Section 312.130—Requests for 

disclosable information in an IND 

and from investigations involving 

an exception from informed consent 

under § 50.24. 

Sections 312.310(b); 312.305(b)— 

Submissions related to expanded 

access and treatment of an 

individual patient. 

Section 312.310(d)—Submissions 

related to emergency use of an 

investigational new drug. 

Sections 312.315(c); 312.305(b)— 

Submissions related to expanded 

access and treatment of an 

intermediate-size patient 

population. 

Section 312.320—Submissions related 

to a treatment IND or treatment 

protocol. 

II. Recordkeeping Requirements 

Section 312.52(a)—Transfer of 

obligations to a contract research 

organization. 

Section 312.57—Sponsor recordkeeping 

on the investigational drug. 

Section 312.59—Sponsor recordkeeping 

of disposition of unused supply of 

drugs. Estimates for the information 

collection in this requirement are 

included under § 312.57. 

Section 312.62(a)—Investigator 

recordkeeping of disposition of 

drugs. 

Section 312.62(b)—Investigator 

recordkeeping of case histories of 

individuals. 

Section 312.120(d)—Recordkeeping 

requirements for submissions 

related to foreign clinical studies 

not conducted under an IND. 

Estimates for the information 

collection in this requirement are 

included under § 312.57. 

Section 312.160(a)(3)—Records 

pertaining to the shipment of drugs 

for investigational use in laboratory 

research animals or in vitro tests. 

Section 312.160(c)—Shipper records of 

alternative disposition of unused 

drugs. 

In the Federal Register of November 

5, 2014 (79 FR 65663), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received 24 

comments, however, these comments 

did not address the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

312.2(e), Requests for FDA advice on the applicability of 

part 312 to a planned clinical investigation .................... 800 1 800 24 19,200 

312.8, Requests to charge for an investigational drug ..... 56 1 .25 70 48 3,360 

312.10, Requests to waive a requirement in part 312 ...... 50 1 .76 88 24 2,112 

312.23(a) through (f), IND content and format (including 

Form FDA 1571) ............................................................ 1,689 1 .57 2,648 1,600 4,236,800 

312.30(a) through (e), Protocol amendments ................... 3,739 5 .77 21,588 284 6,130,992 

312.31 (b), Information amendments ................................ 4,537 3 .39 15,377 100 1,537,700 

312.32(c) and (d), IND Safety reports ............................... 755 24 .28 18,332 32 586,624 

312.33(a) through (f), IND Annual reports ......................... 2,877 2 .76 7,953 360 2,863,080 

312.38(b) and (c), Notifications of withdrawal of an IND .. 862 1 .54 1,328 28 37,184 

312.42, Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 158 1 .30 205 284 58,220 

312.44(c) and (d), Sponsor responses to FDA when IND 

is terminated ................................................................... 12 1 12 16 192 

312.45(a) and (b), Sponsor requests for or responses to 

an inactive status determination of an IND by FDA ...... 260 1 .73 451 12 5,412 

312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings 

and ‘‘Pre-NDA’’ meetings ............................................... 225 1 .86 419 160 67,040 

312.53(c), Investigator reports submitted to the sponsor, 

including Form FDA 1572, curriculum vitae, clinical 

protocol, and financial disclosure. (Third party disclosure) ............................................................................... 1,444 8 .38 12,087 80 966,960 

312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under 21 CFR 50.24 .............................................. 7 5 35 48 1,680 

312.54(b), Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in § 50.24(a). (Includes 

third party disclosure) ..................................................... 7 1 7 48 336 

312.55(a), Investigator brochures submitted by the sponsor to each investigator. (Third party disclosure) .......... 590 3 .50 2,067 48 99,216 

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11452 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

312.55(b), Sponsor reports to investigators on new observations, especially adverse reactions and safe use. 

(Third party disclosure) .................................................. 590 3 .50 2,067 48 99,216 

312.56(b),(c), and (d), Sponsor notifications to FDA and 

others resulting from: (1) The sponsor’s monitoring of 

all clinical investigations and determining that an investigator is not in compliance with the investigation 

agreements; (2) the sponsor’s review and evaluation of 

the evidence relating to the safety and effectiveness of 

the investigational drug; and (3) the sponsor’s determination that the investigational drug presents an unreasonable and significant risk to subjects. (Includes 

third party disclosure) ..................................................... 3,584 6 .52 23,355 80 1,868,400 

312.58(a), Sponsor’s submissions of clinical investigation 

records to FDA on request during FDA inspections ...... 60 1 60 8 480 

312.64, Investigator reports to the sponsor, including 

progress reports, safety reports, final reports, and financial disclosure reports. (Third party disclosure) ....... 1,444 1 1,444 24 34,656 

312.70, During the disqualification process of a clinical 

investigator by FDA, the number of investigator responses or requests to FDA following FDA’s notification to an investigator of its failure to comply with investigation requirements ................................................ 4 1 4 40 160 

312.110(b)(4) and (b)(5), Written certifications and written 

statements submitted to FDA relating to the export of 

an investigational drug ................................................... 11 26 .28 289 75 21,675 

312.120(b), Submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not 

conducted under an IND ................................................ 1,414 8 .63 12,198 32 390,336 

312.120(c), Waiver requests submitted to FDA related to 

the use of foreign clinical studies not conducted under 

an IND ............................................................................ 35 2 .34 82 24 1,968 

312.130, Requests for disclosable information in an IND 

and for investigations involving an exception from informed consent under § 50.24 ....................................... 3 1 3 8 24 

312.310(b) and 312.305(b), Submissions related to expanded access and treatment of an individual patient .. 228 1 .76 401 8 3,208 

312.310(d), Submissions related to emergency use of an 

investigational new drug ................................................. 410 2 .19 899 16 14,384 

312.315(c) and 312.305(b), Submissions related to expanded access and treatment of an intermediate-size 

patient population ........................................................... 44 7 .07 311 120 37,320 

312.320(b), Submissions related to a treatment IND or 

treatment protocol .......................................................... 12 12 .67 152 300 45,600 

Total ............................................................................ ........................ .......................... ........................ ........................ 19,134,039 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

312.52(a), Sponsor records for the transfer of obligations 

to a contract research organization ............................... 335 1 .50 503 2 1,006 

312.57, Sponsor recordkeeping showing the receipt, 

shipment, or other disposition of the investigational 

drug, and any financial interests .................................... 1,689 1 1,689 100 168,900 

312.62(a), Investigator recordkeeping of the disposition 

of drugs .......................................................................... 1,444 1 1,444 40 57,760 

312.62(b), Investigator recordkeeping of case histories of 

individuals ....................................................................... 1,444 1 1,444 40 57,760 

312.160(a)(3), Records pertaining to the shipment of 

drugs for investigational use in laboratory research animals or in vitro tests ....................................................... 547 1 .40 782 * 0.50 391 

312.160(c), Shipper records of alternative disposition of 

unused drugs .................................................................. 547 1 .40 782 * 0.50 391 

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Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 11453 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR HUMAN DRUGS 1—Continued 

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Total ............................................................................ ........................ .......................... ........................ ........................ 286,190 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

* Thirty (30) minutes. 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

312.2(e), Requests for FDA advice on the applicability of 

part 312 to a planned clinical investigation .................... 217 1 .18 255 24 6,120 

312.8, Requests to charge for an investigational drug ..... 20 1 .50 30 48 1,440 

312.10, Requests to waive a requirement in part 312 ...... 2 1 2 24 48 

312.23(a) through (f), IND content and format .................. 335 1 .35 452 1,600 723,200 

312.30(a) through (e), Protocol amendments ................... 694 5 .84 4,050 284 1,150,200 

312.31(b), Information amendments .................................. 77 2 .43 187 100 18,700 

312.32(c) and (d), IND Safety reports ............................... 161 8 .83 1,421 32 45,472 

312.33(a) through (f), IND Annual reports ......................... 745 2 .14 1,595 360 574,200 

312.38(b) and (c), Notifications of withdrawal of an IND .. 134 1 .69 227 28 6,356 

312.42, Sponsor requests that a clinical hold be removed, including sponsor submission of a complete response to the issues identified in the clinical hold order 67 1 .30 87 284 24,708 

312.44(c) and (d), Sponsor responses to FDA when IND 

is terminated ................................................................... 34 1 .15 39 16 624 

312.45(a) and (b), Sponsor requests for or responses to 

an inactive status determination of an IND by FDA ...... 55 1 .38 76 12 912 

312.47, Meetings, including ‘‘End-of-Phase 2’’ meetings 

and ‘‘Pre-NDA’’ meetings ............................................... 88 1 .75 154 160 24,640 

312.53(c), Investigator reports submitted to the sponsor, 

including Form FDA–1572, curriculum vitae, clinical 

protocol, and financial disclosure ................................... 453 6 .33 2,869 80 229,520 

312.54(a), Sponsor submissions to FDA concerning investigations involving an exception from informed consent under § 50.24 .......................................................... 1 1 1 48 48 

312.54(b), Sponsor notifications to FDA and others concerning an IRB determination that it cannot approve research because it does not meet the criteria in the exception from informed consent in § 50.24(a) ................. 1 1 1 48 48 

312.55(a), Number of investigator brochures submitted 

by the sponsor to each investigator ............................... 239 1 .91 457 48 21,936 

312.55(b), Number of sponsor reports to investigators on 

new observations, especially adverse reactions and 

safe use .......................................................................... 243 4 .95 1,203 48 57,744 

312.56(b), (c), and (d), Sponsor notifications to FDA and 

others resulting from: (1) The sponsor’s monitoring of 

all clinical investigations and determining that an investigator is not in compliance with the investigation 

agreements; (2) the sponsor’s review and evaluation of 

the evidence relating to the safety and effectiveness of 

the investigational drug; and (3) the sponsor’s determination that the investigational drug presents an unreasonable and significant risk to subjects .................... 108 2 .21 239 80 19,120 

312.58(a), Number of sponsor’s submissions of clinical 

investigation records to FDA on request during FDA inspections ........................................................................ 7 1 7 8 56 

312.64, Number of investigator reports to the sponsor, including progress reports, safety reports, final reports, 

and financial disclosure reports ..................................... 2,728 3 .82 10,411 24 249,864 

312.70, During the disqualification process of a clinical 

investigator by FDA, the number of investigator responses or requests to FDA following FDA’s notification to an investigator of its failure to comply with investigation requirements ................................................ 5 1 5 40 200 

312.110(b)(4) and (b)(5), Number of written certifications 

and written statements submitted to FDA relating to 

the export of an investigational drug .............................. 18 1 18 75 1,350 

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11454 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices 

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1—Continued 

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

312.120(b), Number of submissions to FDA of ‘‘supporting information’’ related to the use of foreign clinical studies not conducted under an IND ....................... 280 9 .82 2,750 32 88,000 

312.120(c), Number of waiver requests submitted to FDA 

related to the use of foreign clinical studies not conducted under an IND ...................................................... 7 2 .29 16 24 384 

312.130, Number of requests for disclosable information 

in an IND and for investigations involving an exception 

from informed consent under § 50.24 ............................ 350 1 .34 470 8 3,760 

312.310(b) and 312.305(b), Number of submissions related to expanded access and treatment of an individual patient .................................................................. 78 1 .08 84 8 672 

312.310(d), Number of submissions related to emergency use of an investigational new drug ..................... 76 2 .76 210 16 3,360 

312.315(c) and 312.305(b), Number of submissions related to expanded access and treatment of an intermediate-size patient population ..................................... 9 1 9 120 1,080 

312.320(b), Number of submissions related to a treatment IND or treatment protocol ..................................... 1 1 1 300 300 

Total ............................................................................ ........................ .......................... ........................ ........................ 3,254,062 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1

21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

312.52(a), Sponsor records for the transfer of obligations 

to a contract research organization ............................... 75 1 .40 105 2 210 

312.57, Sponsor recordkeeping showing the receipt, 

shipment, or other disposition of the investigational 

drug, and any financial interests .................................... 335 2 .70 904 100 90,400 

312.62(a), Investigator recordkeeping of the disposition 

of drugs .......................................................................... 453 1 453 40 18,120 

312.62(b), Investigator recordkeeping of case histories of 

individuals ....................................................................... 453 1 453 40 18,120 

312.160(a)(3), Records pertaining to the shipment of 

drugs for investigational use in laboratory research animals or in vitro tests ....................................................... 111 1 .40 155 * 0.50 78 

312.160(c), Shipper records of alternative disposition of 

unused drugs .................................................................. 111 1 .40 155 * 0.50 78 

Total ............................................................................ ........................ .......................... ........................ ........................ 127,006 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

* Thirty (30) minutes. 

Dated: February 24, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–04379 Filed 3–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0430] 

Measuring Dystrophin in 

Dystrophinopathy Patients and 

Interpreting the Data; Public Scientific 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public scientific 

workshop; request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public scientific 

workshop to discuss dystrophin protein 

quantification methodologies for human 

tissue. This workshop is being 

cosponsored by the National Institutes 

of Health (NIH). The purpose of the 

workshop is to discuss currently 

available methodologies and to identify 

scientific knowledge gaps and 

opportunities for improving dystrophin 

protein detection in the context of drug 

development. The intended audiences 

for this workshop are scientists and 

clinicians involved in the acquisition, 

measurement, and analysis of proteins 

associated with Duchenne Muscular 

Dystrophy (DMD). 

mstockstill on DSK4VPTVN1PROD with NOTICES