Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1173 

1FDA guidances are available on FDA’s Web page 

at http://www.fda.gov/RegulatoryInformation/

Guidances/default.htm. FDA guidances are issued 

and updated regularly. We recommend you check 

the Web site to ensure that you have the most upto-date version of a guidance. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, http:// 

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm, 

http://www.fda.gov/Food/Guidance

ComplianceRegulatoryInformation/ 

GuidanceDocuments/default.htm, or 

http://www.regulations.gov. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–94 Filed 1–6–11; 8:45 am] 

BILLING CODE 4110–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0643] 

Draft Guidance for Industry on 

Electronic Source Documentation in 

Clinical Investigations; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Electronic Source 

Documentation in Clinical 

Investigations.’’ This document provides 

guidance to sponsors, contract research 

organizations (CROs), data management 

centers, and clinical investigators on 

capturing, using, and archiving 

electronic data in FDA-regulated 

clinical investigations. It also describes 

FDA’s recommended procedures for 

ensuring the reliability, quality, 

integrity, and traceability of electronic 

source data and source records 

maintained at the site for FDA 

inspection. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that FDA 

considers your comments on the draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by April 7, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Critical Path Programs, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4173, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Leonard Sacks, Office of Critical Path 

Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg., 32, rm. 4174, Silver Spring, 

MD 20993–0002, 301–796–8502. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Electronic Source Documentation in 

Clinical Investigations.’’ This guidance 

is intended to be used together with the 

guidances for industry 1 entitled: 

• Computerized Systems Used in 

Clinical Investigations, 

• Part 11, Electronic Records; 

Electronic Signatures—Scope and 

Application, and 

• General Principles of Software 

Validation; Final Guidance for Industry 

and FDA Staff. 

With the increasing use of 

computerized systems in clinical 

investigations, it is common to find 

source data documented in an electronic 

format, e.g., clinical data initially 

documented in electronic health records 

maintained by hospitals and 

institutions, electronic case report 

forms, laboratory reports that are 

electronically generated, electronic 

medical images from devices, and 

electronic diaries provided by study 

subjects. When paper source documents 

are available for review, tracing of data 

in paper-based studies can be performed 

easily. However, when source data is 

electronic, the data is traced through 

complex data capture, transmission, and 

archival processes. This guidance 

recommends practices that will help 

ensure that electronic source data and 

source records are accurate, legible, 

original, attributable (e.g., user name 

and password), and contemporaneously 

entered; and meet the regulatory 

requirements for recordkeeping and 

retention. 

The following specific topics related 

to electronic source data are discussed: 

• The identification of the data 

element as the basic unit of information 

in the electronic case report form; 

• The description of a source of each 

data element; 

• Information about the electronic 

creation, modification, transmission, 

and storage of source data and 

documents; 

• Investigator responsibilities with 

respect to reviewing and archiving 

electronic data; 

• Transmission of the data to the 

sponsor and/or other designated parties; 

and 

• Preservation of data integrity. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on capturing, using, and archiving 

electronic data in FDA-regulated 

clinical investigations. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in §§ 312.62(b) and 

312.64(b) have been approved under 

OMB control number 0910–0014; and 

the collection of information in 

§§ 812.140 and 812.150 has been 

approved under OMB control number 

0910–0078. 


jdjones on DSK8KYBLC1PROD with NOTICES
1174 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

1A ‘‘new drug’’ is defined by the FD&C Act as a 

drug that ‘‘is not generally recognized, among 

experts qualified by scientific training and 

experience to evaluate the safety and effectiveness 

of drugs, as safe and effective for use under the 

conditions prescribed, recommended, or suggested 

in the labeling thereof, except that such a drug not 

so recognized shall not be deemed to be a ‘new 

drug’ if at any time prior to the enactment of this 

FD&C Act it was subject to the Food and Drugs Act 

of June 30, 1906, as amended, and if at such time 

its labeling contained the same representations 

concerning the conditions of its use * * *.’’ (21 

U.S.C. 321(p)). 

2Section 310.6(b)(1) (21 CFR 310.6(b)(1)) 

provides: ‘‘An identical, related, or similar drug 

includes other brands, potencies, dosage forms, 

salts, and esters of the same drug moiety as well as 

of any drug moiety related in chemical structure or 

known pharmacological properties.’’ 

3 38 FR 34481 (December 14, 1973). 

4 38 FR 4006 (February 9, 1973) and 37 FR 15022 

(July 27, 1972). 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/default.htm, 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/GuidanceDocuments/

default.htm, and http:// 

www.regulations.gov. 

Dated: January 1, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–73 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–1981–N–0361 (formerly 

81N–0391), FDA–1981–N–0077 (formerly 

81N–0393), FDA–1981–N–0248 (formerly 

81N–0396), FDA–1982–N–0225 (formerly 

82N–0078), FDA–1982–N–0046 (formerly 

82N–0095), FDA–1982–N–0264 (formerly 

82N–0096), FDA–1982–N–0310 (formerly 

82N–0311), and FDA–1983–N–0137 

(formerly 83N–0095); DESI 5213, 6290, 6303, 

6514, 8658, 11935, and 12152] 

Drugs for Human Use; Drug Efficacy 

Study Implementation; Oral 

Prescription Drugs Offered for Relief of 

Symptoms of Cough, Cold, or Allergy; 

Withdrawal of Hearing Requests; 

Opportunity To Affirm Outstanding 

Hearing Requests; Final Resolution of 

Dockets 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that all outstanding hearing requests 

pertaining to Docket Nos. 81N–0391, 

82N–0078, and 82N–0311 have been 

withdrawn and therefore, shipment in 

interstate commerce of the products 

identified in those dockets, or any 

identical, related, or similar product 

that is not the subject of an approved 

new drug application (other than an 

over-the-counter (OTC) product that 

complies with an applicable OTC 

monograph), is unlawful as of the 

effective date of this notice. FDA is also 

offering an opportunity to affirm 

outstanding hearing requests in Docket 

Nos. 81N–0393, 81N–0396, 82N–0095, 

82N–0096, and 83N–0095. FDA will 

assume that companies with 

outstanding hearing requests that do not 

respond to this notice are no longer 

interested in pursuing their requests, 

and will deem the requests withdrawn. 

DATES: Effective Date: This notice is 

effective February 7, 2011. Hearing 

requests must be affirmed by notifying 

FDA by February 7, 2011. Hearing 

requests not affirmed within that time 

frame will be deemed withdrawn. 

ADDRESSES: All communications in 

response to this notice should be 

identified with the appropriate docket 

number, and directed to the appropriate 

office listed as follows: 

To affirm or withdraw hearing 

requests: Sakineh Walther, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002. 

All other communications: Sakineh 

Walther, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 5242, Silver Spring, 

MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Sakineh Walther, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5242, 

Silver Spring, MD 20993–0002, 301– 

796–3349, e-mail: 

sakineh.walther@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

When initially enacted in 1938, the 

Federal Food, Drug, and Cosmetic Act 

(FD&C act) required that ‘‘new drugs’’ be 

approved for safety by FDA before they 

could legally be sold in interstate 

commerce.1 To this end, the FD&C Act 

made it the sponsor’s responsibility, 

prior to marketing a new drug, to submit 

a new drug application (NDA) to FDA 

to prove that its drug was safe. Between 

1938 and 1962, if a drug obtained 

approval, FDA considered drugs that 

were identical, related, or similar (IRS) 2

to the approved drug to be ‘‘covered’’ by 

that approval, and allowed those IRS 

drugs to be marketed without 

independent approval. 

In 1962, Congress amended the act to 

require that new drugs be proven 

effective for their labeled indications, as 

well as safe, in order to obtain FDA 

approval. This amendment also 

necessitated that FDA conduct a 

retrospective evaluation of the 

effectiveness of the drug products that 

FDA had approved as safe between 1938 

and 1962. FDA contracted with the 

National Academy of Science/National 

Research Council (NAS/NRC) to make 

an initial evaluation of the effectiveness 

of over 3,400 products that had been 

approved only for safety between 1938 

and 1962. The NAS/NRC reports for 

these drug products were submitted to 

FDA in the late 1960s and early 1970s. 

The agency reviewed and re-evaluated 

the reports and published its findings in 

Federal Register notices. FDA’s 

administrative implementation of the 

NAS/NRC reports was called the Drug 

Efficacy Study Implementation (DESI). 

DESI covered the approximately 3,400 

products specifically reviewed by the 

NAS/NRC, as well as the even larger 

number of IRS products that entered the 

market without FDA approval. 

In the early 1970s, FDA granted 

temporary exemptions 3 from the time 

limits established 4 for completing 

certain phases of the DESI program for 

certain oral prescription drugs offered 

for relief of cough, cold, allergy, and 

related symptoms. The exemptions were 

granted because of the close relationship 

between these prescription drugs and 

drugs sold over the counter (OTC) that 

were subject to the ongoing OTC drug 

review (see 21 CFR part 330). 

Postponement of final evaluations of 

these DESI prescription products 

enabled the agency to consider the 

recommendations of the OTC review 

panel in addition to any evidence 

submitted by NDA holders and other 

parties in response to various DESI 

notices covering relevant products. 

All drugs covered by the DESI review 

are ‘‘new drugs’’ under the FD&C Act. If 

FDA’s final DESI determination 

classifies a drug product as lacking 

substantial evidence of effectiveness for 

one or more indications, that drug 

product and those IRS to it may no 

longer be marketed for such indications 

and are subject to enforcement action as 

unapproved new drugs. If FDA’s final 

DESI determination classifies the drug 

product as effective for one or more of 

its labeled indications, the drug can be 

marketed for such indications, provided 


jdjones on DSK8KYBLC1PROD with NOTICES