508 Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 

Statutory Authority: Section 5(a) of the 

‘‘Torture Victims Relief Act of 1998,’’ Public 

Law 105–320 (22 U.S.C. 2152 note). 

Melody Wayland, 

Senior Grants Policy Specialist, Office of 

Administration. 

[FR Doc. 2014–30906 Filed 1–5–15; 8:45 am] 

BILLING CODE 4184–46–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1081] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; 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 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by February 5, 

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 0910–0701. 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. 

Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Medical Products and Dietary 

Supplements During an Influenza 

Pandemic; Availability (OMB Control 

Number 0910–0701)—Extension 

The guidance includes 

recommendations for planning, 

notification, and documentation for 

firms that report postmarketing adverse 

events. The guidance recommends that 

each firm’s pandemic influenza 

continuity of operations plan (COOP) 

include instructions for reporting 

adverse events, including a plan for the 

submission of stored reports that were 

not submitted within regulatory 

timeframes. The 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 guidance, we estimate that 

approximately 5,000 firms will add the 

following 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 guidance that firms unable to fulfill 

normal adverse event reporting 

requirements maintain documentation 

of the conditions that prevent them from 

meeting these requirements, 

maintaining 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 approximately 500 

firms will each need approximately 8 

hours to maintain the records. 

Therefore, the total recordkeeping 

burden that would result from the 

guidance would be 258,000 hours. 

The 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 

OMB under the PRA (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 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 Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 379aa and 379aa–1), 

which include collections of 

information approved under OMB 

control numbers 0910–0636 and 0910– 

0635. 

In the Federal Register of August 11, 

2014 (79 FR 46839), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one comment. 

The comment said that during an 

influenza pandemic, FDA should not 

put forth a policy of reduced reporting, 

especially for newly approved drugs 

and vaccines. The comment 

recommended that FDA ask companies 

to modify their contingency plans by 

either leveraging the company’s remote 

call center locations not affected by the 

pandemic or by outsourcing their safety 

reporting to such locations. The 

comment stated that at minimum, FDA 

should require weekly reporting or 

establish a threshold number of reports 

that a company must report to FDA. The 

comment added that FDA should 

specifically require reporting on newly 

approved drugs or vaccines for which 

there is little safety information. 

FDA response: The Guidance for 

Industry on Postmarketing Adverse 

Event Reporting for Medical Products 

and Dietary Supplements During an 

Influenza Pandemic does not describe 

an approach of reduced reporting during 

an influenza pandemic. Rather, the 

guidance states that ‘‘normal adverse 

event reporting processes should be 

maintained to the maximum extent 

possible’’ (see section III.C.1, page 3). 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 3 / Tuesday, January 6, 2015 / Notices 509 

FDA also provides recommendations on 

how to prioritize reporting when 

regulatory timelines cannot be met due 

to limited resources during a pandemic, 

so that FDA continues to receive critical 

safety information in a timely manner. 

For example, table 1 of the guidance 

outlines how companies should 

prioritize their submission of 

postmarketing safety reports during an 

influenza pandemic if normal processes 

of mandatory adverse event reporting 

are not feasible because of high 

employee absenteeism: Reports for 

pandemic influenza vaccines, drugs and 

biological products labeled for the 

treatment of influenza, drugs and 

biologics approved for less than three 

years, and products with special 

concerns as specified by FDA. The list 

includes reporting on newly approved 

products as the comment recommended. 

The guidance provides resources for 

companies establishing a COOP plan, 

but specifying the content of the COOP 

plans as suggested by the comment is 

beyond the scope of the guidance. 

Instead, the guidance provides the more 

general recommendation that ‘‘each 

firm’s pandemic influenza COOP plan 

should include instructions for 

reporting adverse events and the 

submission of any stored reports not 

submitted in the regulatory timeframes’’ 

(see section III.B, page 2). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of reporting Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

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

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden per 

recordkeeper 

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 collection of information. 

Dated: December 30, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–30907 Filed 1–5–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–P–0980] 

Determination That REYATAZ 

(Atazanavir Sulfate) Capsules, 100 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that REYATAZ (atazanavir 

sulfate) capsules, 100 milligrams (mg), 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for atazanavir 

sulfate, 100 mg, if all other legal and 

regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Na’Im R. Moses, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6224, 

Silver Spring, MD 20993–0002, 240– 

402–3990. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

REYATAZ (atazanavir sulfate) 

capsules, 100 mg, is the subject of NDA 

21–567, held by Bristol-Myers Squibb, 

and initially approved on June 20, 2003. 


tkelley on DSK3SPTVN1PROD with NOTICES