1170 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 7, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0553. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

301–796–5156, e-mail: 

Daniel.Gittleson@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. 

Medical Devices: Recommended 

Glossary and Educational Outreach to 

Support Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use— 

(OMB Control Number 0910–0553)— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded. Section 351 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 262) establishes requirements 

that manufacturers of biological 

products must submit a license 

application for FDA review and 

approval prior to marketing a biological 

product for introduction into interstate 

commerce. 

In the Federal Register of November 

30, 2004 (69 FR 69606), FDA published 

a notice of availability of the guidance 

entitled ‘‘Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use.’’ 

The guidance document provides 

guidance for the voluntary use of 

selected symbols in place of text in 

labeling. It provides the labeling 

guidance required for: (1) In vitro 

diagnostic devices (IVDs), intended for 

professional use under 21 CFR 809.10, 

FDA’s labeling requirements for IVDs; 

and (2) FDA’s labeling requirements for 

biologics, including IVDs under 21 CFR 

parts 610 and 660. Under section 502(c) 

of the FD&C Act, a drug or device is 

misbranded, ‘‘* * *If any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ 

The guidance document recommends 

that a glossary of terms accompany each 

IVD to define the symbols used on that 

device’s labels and/or labeling. 

Furthermore, the guidance recommends 

an educational outreach effort to 

enhance the understanding of newly 

introduced symbols. Both the glossary 

and educational outreach information 

will help to ensure that IVD users will 

have enough general familiarity with the 

symbols used, as well as provide a quick 

reference for available materials, thereby 

further ensuring that such labeling 

satisfies the labeling requirements under 

section 502(c) of the FD&C Act and 

section 351 of the PHS Act. 

The likely respondents for this 

collection of information are IVD 

manufacturers who plan to use the 

selected symbols in place of text on the 

labels and/or labeling of their IVDs. 

The glossary activity is inclusive of 

both domestic and foreign IVD 

manufacturers. FDA receives 

submissions from approximately 689 

IVD manufacturers annually. The 

number of hours per response for the 

glossary and educational outreach 

activities were derived from 

consultation with a trade association 

and FDA personnel. The 4-hour 

estimate for a glossary is based on the 

average time necessary for a 

manufacturer to modify the glossary for 

the specific symbols used in labels or 

labeling for the IVDs manufactured. 

In the Federal Register of October 5, 

2010 (75 FR 61494), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section 502 of the FD&C Act/Section 351 of the PHS Act Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Glossary ............................................................................... 689 1 689 4 2,756 

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

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–74 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0610] 

Draft Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic; 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 ‘‘Postmarketing 

Adverse Event Reporting for Medical 

Products and Dietary Supplements 

During an Influenza Pandemic.’’ The 

draft guidance discusses FDA’s 

intended approach to enforcement of 

adverse event reporting requirements for 

drugs, biologics, medical devices, and 

dietary supplements during an 

influenza pandemic. The agency makes 

recommendations to industry for 

focusing limited resources on reports 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1171 

related to products indicated for the 

prevention and treatment of influenza 

and other specific types of reports 

indicated in the draft guidance. This 

draft guidance is a revision of the draft 

guidance for industry of the same title 

published on December 16, 2008. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by March 8, 2011. 

Submit written comments on the 

proposed collection of information by 

March 8, 2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that 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 to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Regarding pandemic influenza: 

Carmen Maher, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

4146, Silver Spring, MD 20993–0002, 

301–796–8510. 

Regarding human drug products: 

Solomon Iyasu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4447, 

Silver Spring, MD 20993–0002, 301– 

796–2370. 

Regarding human biological products: 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852– 

1448, 301–827–6210. 

Regarding medical device products: 

Deborah Moore, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 3230, Silver Spring, 

MD 20993–0002, 301–796–6106. 

Regarding dietary supplements: John 

Sheehan, Center for Food Safety and 

Applied Nutrition (HFS–315), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1488. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic.’’ In the Federal 

Register of December 16, 2008 (73 FR 

76364), FDA published notice of the 

availability of a draft guidance of the 

same title. FDA anticipates that during 

an influenza pandemic, industry and 

FDA workforces may be reduced while 

reporting of adverse events related to 

widespread use of medical products 

indicated for the treatment and 

prevention of influenza may increase, 

although the extent of these possible 

changes is unknown. The revised draft 

guidance discusses FDA’s intended 

approach to enforcement of adverse 

event reporting requirements for drugs, 

biologics, medical devices, and dietary 

supplements during an influenza 

pandemic. 

II. Revisions to the 2008 Draft Guidance 

FDA is issuing a revised draft 

guidance that includes 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The revised draft guidance 

recommends that each firm’s pandemic 

influenza continuity of operations plan 

(COOP) include instructions for 

reporting adverse events and a plan for 

the submission of stored reports that 

were not submitted within regulatory 

timeframes. The revised draft guidance 

recommends that firms that are unable 

to fulfill normal adverse event reporting 

requirements during an influenza 

pandemic do the following: 

• Document the conditions that 

prevent them from meeting normal 

reporting requirements, 

• Notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when these conditions exist and when 

the reporting process is restored, and 

• Maintain records to identify what 

reports have been stored. 

These recommendations represent 

collections of information under the 

Paperwork Reduction Act of 1995 (the 

PRA) (44 U.S.C. 3501–3520) discussed 

in section IV of this document. In 

issuing this revised draft guidance, FDA 

considered all comments that were 

submitted in response to the December 

2008 draft guidance. Most comments 

requested that greater clarity be 

provided in certain sections; FDA has 

revised these sections accordingly. 

This draft guidance does not address 

monitoring and reporting of adverse 

events that might be imposed as a 

condition of authorization for products 

authorized for emergency use under 

section 564 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 360bbb–3). This draft guidance 

also does not address monitoring and 

reporting of adverse events as required 

by regulations establishing the 

conditions for investigational use of 

drugs, biologics, and devices. (See 21 

CFR parts 312 and 812.) 

This 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 postmarketing adverse event 

reporting for medical products and 

dietary supplements during pandemic 

influenza. 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. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either 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. 

IV. Paperwork Reduction Act of 1995 

Under the PRA, Federal agencies must 

obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information that they 

conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA, 44 U.S.C. 

3506(c)(2)(A), requires Federal agencies 

to provide a 60-day notice in the 

Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing this 

notice of the proposed collection of 

information set forth in this document. 


jdjones on DSK8KYBLC1PROD with NOTICES
1172 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

With respect to the collection of 

information associated with this draft 

guidance, FDA invites comments on the 

following topics: (1) Whether the 

proposed information collected is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimated 

burden of the proposed information 

collected, including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(4) ways to minimize the burden of 

information collected on the 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

The draft guidance explains FDA’s 

approach to enforcement of adverse 

event reporting requirements for drugs, 

biologics, medical devices, and dietary 

supplements during an influenza 

pandemic, including an intent not to 

object to changes in the timing of 

submission of certain reports during 

some stages of the pandemic response. 

The Agency recommends that each 

firm’s pandemic influenza COOP 

include instructions for reporting 

adverse events, including a plan for the 

submission of stored reports that were 

not submitted within regulatory 

timeframes. The draft guidance explains 

that firms that are unable to fulfill 

normal adverse event reporting 

requirements during an influenza 

pandemic should: (1) Maintain 

documentation of the conditions that 

prevent them from meeting normal 

reporting requirements, (2) notify the 

appropriate FDA organizational unit 

responsible for adverse event reporting 

compliance when the conditions exist 

and when the reporting process is 

restored, and (3) maintain records to 

identify what reports have been stored. 

Based on the number of 

manufacturers that would be covered by 

the draft guidance, we estimate that 

approximately 5,000 firms will add to 

their COOP: (1) Instructions for 

reporting adverse events and (2) a plan 

for submitting stored reports that were 

not submitted within regulatory 

timeframes. We estimate that each firm 

will take approximately 50 hours to 

prepare the adverse event reporting plan 

for its COOP. 

We estimate that approximately 500 

firms will be unable to fulfill normal 

adverse event reporting requirements 

because of conditions caused by an 

influenza pandemic and that these firms 

will notify the appropriate FDA 

organizational unit responsible for 

adverse event reporting compliance 

when the conditions exist. Although we 

do not anticipate such pandemic 

influenza conditions to occur every 

year, for purposes of the PRA, we 

estimate that each of these firms will 

notify FDA approximately once each 

year, and that each notification will take 

approximately 8 hours to prepare and 

submit. 

Concerning the recommendation in 

the draft guidance that firms unable to 

fulfill normal adverse event reporting 

requirements maintain documentation 

of the conditions that prevent them from 

meeting these requirements and also 

maintain records to identify what 

adverse event reports have been stored 

and when the reporting process is 

restored, we estimate that 

approximately 500 firms will each need 

approximately 8 hours to maintain the 

documentation and that approximately 

500 firms will each need approximately 

8 hours to maintain the records. 

Therefore, the total recordkeeping 

burden that would result from the draft 

guidance would be 258,000 hours. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA’s adverse 

event reporting requirements in 21 CFR 

310.305, 314.80, 314.98, 600.80, 

606.170, 640.73, 1271.350, and part 803. 

These regulations contain collections of 

information that 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) and 

are approved under OMB control 

numbers 0910–0116, 0910–0291, 0910– 

0230, 0910–0308, 0910–0437, and 0910– 

0543. In addition, the draft guidance 

also refers to adverse event reports for 

nonprescription human drug products 

marketed without an approved 

application and dietary supplements 

required under sections 760 and 761 of 

the FD&C Act (21 U.S.C. 379aa and 

379aa–1), which include collections of 

information approved under OMB 

control numbers 0910–0636 and 0910– 

0635. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

response Total hours 

Notify FDA when normal reporting is not feasible ............... 500 1 500 8 4,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,000 

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

TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1

Number of 

recordkeepers 

Number of 

records per 

recordkeeping 

Total records Hours per 

record Total hours 

Add adverse event reporting plan to COOP ....................... 5,000 1 5,000 50 250,000 

Maintain documentation of influenza pandemic conditions 

and resultant high absenteeism ....................................... 500 1 500 8 4,000 

Maintain records to identify what reports have been stored 

and when the reporting process was restored ................ 500 1 500 8 4,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 258,000 

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


jdjones on DSK8KYBLC1PROD with NOTICES
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