80 FR 79912 - Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 246 (December 23, 2015)

Page Range		79912-79912
FR Document		2015-32252

The Food and Drug Administration (FDA) is correcting a notice entitled ``Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products'' that appeared in the Federal Register of December 15, 2015 (80 FR 77637). The document solicited comments on the bar code label requirements for human drug and biological products. The document was published with an incorrect docket number. This document corrects that error.

Federal Register, Volume 80 Issue 246 (Wednesday, December 23, 2015)

[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Page 79912]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0873]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Bar Code Label Requirement for Human Drug and 
Biological Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
entitled ``Agency Information Collection Activities: Proposed 
Collection; Comment Request; Bar Code Label Requirement for Human Drug 
and Biological Products'' that appeared in the Federal Register of 
December 15, 2015 (80 FR 77637). The document solicited comments on the 
bar code label requirements for human drug and biological products. The 
document was published with an incorrect docket number. This document 
corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy and 
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, December 
15, 2015, in FR Doc. 2015-31402, the following correction is made:
    1. On page 77637, in the second column, the docket number is 
corrected to read FDA-2012-N-0873.

    Dated: December 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32252 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P

79912 Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Notices

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of re-
Number of Total annual Average burden per
Activity sponses per Total hours
respondents responses response
respondent

Pretest .......................................................................... 640 1 640 0.75 (45 minutes) 480
Main Study Screener ................................................... 2,112 1 2,112 0.08 (5 minutes) 169
Main Study ................................................................... 1,056 1 1,056 0.75 (45 minutes) 792

Total ...................................................................... 5,193 1 5,193 ................................ 1,560
1 There are no capital costs or operating and maintenance costs associated with the collection of information.

V. References CFRSearch.cfm?fr=202.1) DEPARTMENT OF HEALTH AND
10. Wingfield A., L.W. Poon, L. Lombardi, D. HUMAN SERVICES
The following references are on
Lowe. ‘‘Speed of Processing in Normal
display in the Division of Dockets
Aging: Effects of Speech Rate, Linguistic Food and Drug Administration
Management (HFA–305), Food and Drug
Structure, and Processing Time.’’ The
Administration, 5630 Fishers Lane, Rm.
Journals of Gerontology. 40(5):579–85,
1061, Rockville, MD 20852, and are [Docket No. FDA–2012–N–0873]
1985.
available for viewing by interested 11. Kramer A.F., S. Hahn, D. Gopher. ‘‘Task
persons between 9 a.m. and 4 p.m., Agency Information Collection
Coordination and Aging: Explorations of
Monday through Friday; they are also Activities: Proposed Collection;
Executive Control Processes in the Task
available electronically at http:// Comment Request; Bar Code Label
Switching Paradigm.’’ Acta
www.regulations.gov. FDA has verified Psychologica. 101:339–78, 1999.
Requirement for Human Drug and
the Web site addresses, as of the date 12. Naveh-Benjamin M., J. Guez, A. Kilb, S. Biological Products; Correction
this document publishes in the Federal Reedy. ‘‘The Associative Memory Deficit
Register, but Web sites are subject to of Older Adults: Further Support Using AGENCY: Food and Drug Administration,
change over time. Face-Name Associations.’’ Psychology HHS.
1. Zhong W., H. Maradit-Kremers, J.L. St. and Aging. 19(3):541–6, 2004.
Sauver, et al., ‘‘Age and Sex Patterns of ACTION: Notice; correction.
13. Sommers M.S., N. Tye-Murray, B. Spehar.
Drug Prescribing in a Defined American
Population.’’ Mayo Clinic Proceedings. ‘‘Auditory-Visual Speech Perception and SUMMARY: The Food and Drug
88(7):697–707, 2013. Auditory-Visual Enhancement in
Administration (FDA) is correcting a
2. Depp C.A., D.A. Schkade, W.K. Thompson, Normal-Hearing Younger and Older
notice entitled ‘‘Agency Information
D.V. Jeste. ‘‘Age, Affective Experience, Adults.’’ Ear and Hearing. 26(3):263–75,
and Television Use.’’ American Journal 2005.
Collection Activities: Proposed
of Preventative Medicine. 39:173–8, 14. Watson J.M., K.B. McDermott, D.A. Collection; Comment Request; Bar Code
2010. Balota. ‘‘Attempting to Avoid False Label Requirement for Human Drug and
3. Agrawal Y., E.A. Platz, J.K. Niparko. Memories in the Deese/Roediger- Biological Products’’ that appeared in
‘‘Prevalence of Hearing Loss and the Federal Register of December 15,
Differences by Demographic McDermott Paradigm: Assessing the
Characteristics Among US Adults.’’ Combined Influence of Practice and 2015 (80 FR 77637). The document
Archives of Internal Medicine. Warnings in Young and Old Adults.’’ solicited comments on the bar code
168(14):1522–30, 2008. Memory and Cognition. 32(1):135–41, label requirements for human drug and
4. Cruickshanks K.J., T.L. Wiley, T.S. Tweed, 2004. biological products. The document was
et al., ‘‘Prevalence of Hearing Loss in 15. Gates G.A., M.P. Feeney, D. Mills. ‘‘Cross- published with an incorrect docket
Older Adults in Beaver Dam, Sectional Age-Changes of Hearing in the number. This document corrects that
Wisconsin.’’ American Journal of Elderly.’’ Ear and Hearing. 29(6):865–74,
Epidemiology. 148(9):879–86, 1998. error.
2008.
5. Lin FR, R. Thorpe, S. Gordon-Salant, L.
Ferrucci. ‘‘Hearing Loss Prevalence and 16. Morrell C.H., S. Gordon-Salant, J.D. FOR FURTHER INFORMATION CONTACT: Lisa
Risk Factors Among Older Adults in the Pearson, L.J. Brant, J.L. Fozard. ‘‘Age- Granger, Office of Policy and Planning,
United States.’’ The Journals of and Gender-Specific Reference Ranges Food and Drug Administration, 10903
Gerontology Series A: Biological for Hearing Level and Longitudinal New Hampshire Ave., Bldg. 32, rm.
Sciences and Medical Sciences. Changes in Hearing Level.’’ Journal of 3330, Silver Spring, MD 20993–0002,
66A(5):582–90, 2011. the Acoustical Society of America. 301–796–9115.
6. Garstecki DC, S.F. Erler. ‘‘Hearing Loss, 100(4)Pt. 1:1949–67, 1996.
Control, and Demographic Factors 17. Cutler A., D. Dahan, W. van Donselaar. SUPPLEMENTARY INFORMATION: In the
Influencing Hearing Aid Use Among ‘‘Prosody in the Comprehension of Federal Register of Tuesday, December
Older Adults.’’ Journal of Speech,
Language, and Hearing Research.
Spoken Language: A Literature Review.’’ 15, 2015, in FR Doc. 2015–31402, the
41:527–37, 1998. Language and Speech. 40(2):141–201, following correction is made:
7. Gates G.A., J.C. Cooper. ‘‘Incidence of 1997. 1. On page 77637, in the second
Hearing Decline in the Elderly.’’ Acta Dated: December 15, 2015. column, the docket number is corrected
Oto-laryngol. 111:240–8, 1991.
Leslie Kux, to read FDA–2012–N–0873.
tkelley on DSK3SPTVN1PROD with NOTICES

8. Humes L.E. ‘‘Speech Understanding in the
Elderly.’’ Journal of the American Associate Commissioner for Policy. Dated: December 15, 2015.
Academy of Audiology. 7:161–7, 1996. [FR Doc. 2015–32251 Filed 12–22–15; 8:45 am] Leslie Kux,
9. U.S. Food and Drug Administration. Code
BILLING CODE 4164–01–P Associate Commissioner for Policy.
of Federal Regulations. Prescription drug
advertisements, 21 CFR Sect. 202.1. [FR Doc. 2015–32252 Filed 12–22–15; 8:45 am]
2013. (http://www.accessdata.fda.gov/ BILLING CODE 4164–01–P
scripts/cdrh/cfdocs/cfCFR/

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Document Created: 2018-03-02 09:21:39
Document Modified: 2018-03-02 09:21:39

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; correction.
Contact		Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3330, Silver Spring, MD 20993-0002, 301-796-9115.
FR Citation		80 FR 79912

80 FR 79912 - Agency Information Collection Activities: Proposed Collection; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 246 (December 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration