80 FR 78740 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 242 (December 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 242 (December 17, 2015)
| Page Range | 78740-78741 | |
| FR Document | 2015-31696 |
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)] [Notices] [Pages 78740-78741] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31696] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act 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 January 19, 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 0910-0734. 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 Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, OMB Control Number 0910-0734--Extension Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require, and if necessary, order labeling changes if FDA becomes aware of new safety information that FDA believes should be included in the labeling of certain prescription drug and biological products approved under section 505 of the FD&C Act or section 351 of the PHS Act (42 U.S.C. 262). Section 505(o)(4) of the FD&C Act applies to prescription [[Page 78741]] drug products with an approved new drug application (NDA) under section 505(b) of the FD&C Act, biological products with an approved biologics license application under section 351 of the PHS Act, or prescription drug products with an approved abbreviated new drug application under section 505(j) of the FD&C Act if the reference listed drug with an approved NDA is not currently marketed. Section 505(o)(4) imposes timeframes for application holders to submit and FDA staff to review such changes, and gives FDA new enforcement tools to bring about timely and appropriate labeling changes. The guidance provides information on the implementation of the new provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes. FDA requires safety labeling changes by sending a notification letter to the application holder. Under section 505(o)(4)(B), the application holder must respond to FDA's notification by submitting a labeling supplement or notifying FDA that the applicant does not believe the labeling change is warranted and submitting a statement detailing the reasons why the application holder does not believe a change is warranted (a rebuttal statement). Based on FDA's experience to date with safety labeling changes requirements under section 505(o)(4), we estimate that approximately 42 application holders will elect to submit approximately one rebuttal statement each year and that each rebuttal statement will take approximately 6 hours to prepare. In addition, in the guidance, FDA states that new labeling prepared in response to a safety labeling change notification should be available on the application holder's Web site within 10 calendar days of approval. FDA estimates that approximately 407 application holders will post new labeling one time each year in response to a safety labeling change notification and that the posting of the labeling will take approximately 4 hours to prepare. In the Federal Register of September 2, 2015 (80 FR 53161), 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of responses per Total annual Average burden Total hours respondents respondent responses per response -------------------------------------------------------------------------------------------------------------------------------------------------------- Rebuttal statement................................................. 42 1 42 6 252 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of submission Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Posting approved labeling on application holder's Web site......... 407 1 407 4 1,628 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collect of information. Dated: December 10, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31696 Filed 12-16-15; 8:45 am] BILLING CODE 4164-01-P
![78740 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
assistance (no script), with a decrease of CDC requested a total of 38,817 ship medical personnel. There is no cost
106 burden hours. respondents and 29,388 burden hours to respondents other than the time
These adjustments result in a decrease annually. The respondents to these required to provide the information
of 55,994 burden hours. information collections are travelers and requested.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Respondent Form responses per
respondents response hours
respondent (in minutes)
Traveler ............................................. Airline Travel Illness or Death Inves- 1,800 1 5/60 150
tigation Form.
Ship Medical Personnel .................... Maritime Conveyance Illness or 750 1 5/60 63
Death Investigation Form.
Traveler ............................................. Land Travel Illness or Death Inves- 100 1 5/60 8
tigation Form.
Traveler ............................................. Ebola Risk Assessment Form (Ill 100 1 15/60 25
traveler interview: English,
French, Arabic, or other as need-
ed).
Traveler ............................................. United States Traveler Health Dec- 9,000 1 15/60 2250
laration (English: Hard Copy,
fillable PDF, electronic portal).
Traveler ............................................. United States Traveler Health Dec- 8,400 1 15/60 2100
laration (French translation guide).
Traveler ............................................. United States Traveler Health Dec- 100 1 15/60 25
laration (Arabic translation guide).
Traveler ............................................. Ebola Risk Assessment Form 810 1 15/60 203
(English hard copy).
Traveler ............................................. Ebola Risk Assessment French 252 1 15/60 63
translation guide.
Traveler ............................................. Ebola Risk Assessment Arabic 5 1 15/60 1
translation guide.
Traveler ............................................. IVR Active Monitoring Survey 9,000 21 4/60 12,600
(English: Recorded).
Traveler ............................................. IVR Active Monitoring Survey 8,400 21 4/60 11,760
(French: Recorded).
Traveler ............................................. IVR Active Monitoring: Arabic trans- 100 21 4/60 140
lation assistance (no script).
Total ........................................... ........................................................... 38,817 ........................ ........................ 29,388
Leroy A. Richardson, ACTION: Notice. and Drug Administration, 8455
Chief, Information Collection Review Office, Colesville Rd., COLE–14526, Silver
Office of Scientific Integrity, Office of the SUMMARY: The Food and Drug Spring, MD 20993–0002, PRAStaff@
Associate Director for Science, Office of the Administration (FDA) is announcing fda.hhs.gov.
Director, Centers for Disease Control and that a proposed collection of
Prevention. information has been submitted to the SUPPLEMENTARY INFORMATION: In
[FR Doc. 2015–31742 Filed 12–16–15; 8:45 am] Office of Management and Budget compliance with 44 U.S.C. 3507, FDA
(OMB) for review and clearance under has submitted the following proposed
BILLING CODE 4163–18–P
the Paperwork Reduction Act of 1995. collection of information to OMB for
DATES: Fax written comments on the
review and clearance.
DEPARTMENT OF HEALTH AND collection of information by January 19, Guidance for Industry on Safety
HUMAN SERVICES 2016. Labeling Changes—Implementation of
ADDRESSES: To ensure that comments on Section 505(o)(4) of the Federal Food,
Food and Drug Administration the information collection are received, Drug, and Cosmetic Act, OMB Control
OMB recommends that written Number 0910–0734—Extension
[Docket No. FDA–2011–D–0164] comments be faxed to the Office of Section 505(o)(4) of the Federal Food,
Information and Regulatory Affairs, Drug, and Cosmetic Act (the FD&C Act)
Agency Information Collection OMB, Attn: FDA Desk Officer, FAX:
Activities; Submission for Office of (21 U.S.C. 355(o)(4)) authorizes FDA to
202–395–7285, or emailed to oira_ require, and if necessary, order labeling
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Management and Budget Review; submission@omb.eop.gov. All
Comment Request; Guidance for changes if FDA becomes aware of new
comments should be identified with the safety information that FDA believes
Industry on Safety Labeling Changes— OMB control number 0910–0734. Also
Implementation of Section 505(o)(4) of should be included in the labeling of
include the FDA docket number found certain prescription drug and biological
the Federal Food, Drug, and Cosmetic in brackets in the heading of this
Act products approved under section 505 of
document. the FD&C Act or section 351 of the PHS
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA Act (42 U.S.C. 262). Section 505(o)(4) of
HHS. PRA Staff, Office of Operations, Food the FD&C Act applies to prescription
VerDate Sep<11>2014 16:53 Dec 16, 2015 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1](https://thefederalregister.org/doc/80_FR_78982/page/1.svg)
![Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78741
drug products with an approved new constitutes new safety information, the each year and that each rebuttal
drug application (NDA) under section procedures involved in requiring safety statement will take approximately 6
505(b) of the FD&C Act, biological labeling changes, and enforcement of hours to prepare.
products with an approved biologics the requirements for safety labeling In addition, in the guidance, FDA
license application under section 351 of changes. states that new labeling prepared in
the PHS Act, or prescription drug FDA requires safety labeling changes response to a safety labeling change
products with an approved abbreviated by sending a notification letter to the notification should be available on the
new drug application under section application holder. Under section application holder’s Web site within 10
505(j) of the FD&C Act if the reference 505(o)(4)(B), the application holder calendar days of approval. FDA
must respond to FDA’s notification by estimates that approximately 407
listed drug with an approved NDA is
submitting a labeling supplement or application holders will post new
not currently marketed. Section
notifying FDA that the applicant does labeling one time each year in response
505(o)(4) imposes timeframes for not believe the labeling change is
application holders to submit and FDA to a safety labeling change notification
warranted and submitting a statement and that the posting of the labeling will
staff to review such changes, and gives detailing the reasons why the
FDA new enforcement tools to bring take approximately 4 hours to prepare.
application holder does not believe a
about timely and appropriate labeling change is warranted (a rebuttal In the Federal Register of September
changes. The guidance provides statement). 2, 2015 (80 FR 53161), FDA published
information on the implementation of Based on FDA’s experience to date a 60-day notice requesting public
the new provisions, including a with safety labeling changes comment on the proposed collection of
description of the types of safety requirements under section 505(o)(4), information. No comments were
labeling changes that ordinarily might we estimate that approximately 42 received.
be required under the new legislation, application holders will elect to submit FDA estimates the burden of this
how FDA plans to determine what approximately one rebuttal statement collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
responses per burden per Total hours
respondents responses
respondent response
Rebuttal statement ............................................................... 42 1 42 6 252
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Type of submission burden per Total hours
respondents per disclosures disclosure
respondent
Posting approved labeling on application holder’s Web site 407 1 407 4 1,628
1 There are no capital costs or operating and maintenance costs associated with this collect of information.
Dated: December 10, 2015. SUMMARY: The Food and Drug Administration, 10903 New Hampshire
Leslie Kux, Administration (FDA) is announcing the Ave., Bldg. 66, Rm. 3615, Silver Spring,
Associate Commissioner for Policy. termination of the Medical Device ISO MD 20993–0002, 301–796–6556.
[FR Doc. 2015–31696 Filed 12–16–15; 8:45 am] Voluntary Audit Report Pilot Program. SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
This program allowed the submission of
ISO audit reports performed by third I. Background
parties, along with audit reports from In the Federal Register of March 19,
DEPARTMENT OF HEALTH AND the preceding 2 years, to determine if 2012 (77 FR 16036), FDA announced the
HUMAN SERVICES the owner or operator of the medical availability of a final guidance entitled
device establishment could be removed ‘‘Guidance for Industry, Third Parties
Food and Drug Administration from FDA’s routine inspection work and Food and Drug Administration
plan for 1 year. FDA is also announcing Staff: Medical Device ISO 13485:2003
[Docket No. FDA–2010–D–0226] its participation in the operational Voluntary Audit Report Submission
phase of the Medical Device Single Pilot Program’’ (Ref. 1). This guidance
Medical Device ISO 13485:2003 Audit Program (MDSAP), which will document was effective on June 5, 2012,
Voluntary Audit Report Pilot Program; allow third parties recognized by the and as stated in the guidance was an
interim measure while developing a
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Termination of Pilot Program; MDSAP consortium to submit audit
Announcement of the Medical Device reports that FDA will utilize for routine single audit program, to implement
Single Audit Program Operational inspections. section 228 of the Food and Drug
Phase Administration Amendments Act of
DATES: This notice is effective March 31, 2007 (Pub. L. 110–85), which amended
AGENCY: Food and Drug Administration, 2016. section 704(g)(7) of the Federal Food,
HHS. FOR FURTHER INFORMATION CONTACT: Drug, and Cosmetic Act (21 U.S.C.
Robert Ruff, Center for Devices and 374(g)(7)). The pilot allowed the owner
ACTION: Notice.
Radiological Health, Food and Drug or operator of the medical device
VerDate Sep<11>2014 18:13 Dec 16, 2015 Jkt 238001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\17DEN1.SGM 17DEN1](https://thefederalregister.org/doc/80_FR_78982/page/2.svg)
Document Created: 2018-03-02 09:17:43
Document Modified: 2018-03-02 09:17:43
| 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 January 19, 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 | 80 FR 78740 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR